Prevention of Future Deaths reports · 2025

Susan Lakin

Regulation 28 report to prevent future deaths, reference 2025-0188, written 11 Apr 2025. A coroner writes one of these when an inquest reveals a risk that could cause further deaths unless something changes.

Date of report11 Apr 2025
Reference2025-0188
DeceasedSusan Lakin
CoronerIsobel Thistlethwaite
Coroner areaRutland and North Leicestershire
CategoryProduct related deaths
Sourcejudiciary.uk record · original PDF
Responses published3

The report

Text extracted from the PDF text layer. Reproduced verbatim, including the scan's own layout.

REGULATION 28: REPORT TO PREVENT FUTURE DEATHS

NOTE: This form is to be used after an inquest.

REGULATION 28 REPORT TO PREVENT DEATHS

THIS REPORT IS BEING SENT TO:

The Medicine and Healthcare Products and Regulatory Agency
The Department for Health and Social Care

1

CORONER

I am Miss I THISTLETHWAITE, His Majesty's Assistant Coroner for the coroner area of Rutland and
North Leicestershire.

2

CORONER’S LEGAL POWERS

I make this report under paragraph 7, Schedule 5, of the Coroners and Justice Act 2009 and
regulations 28 and 29 of the Coroners (Investigations) Regulations 2013.

3

INVESTIGATION and INQUEST

On 05 March 2024 I commenced an investigation into the death of Susan Marion LAKIN aged 72. The
investigation concluded at the end of the inquest on . The conclusion of the inquest was that:

Accidental death

The cause of death was established as:

I a Respiratory compromise by Support Belt
I b Postural Impairment
I c Corticobasal Syndrome and Atypical Parkinson's Disease

II

4

CIRCUMSTANCES OF THE DEATH

Mrs Lakin was a 72 year old female who lived alone with the support of her family and carers. Mrs
Lakin experienced a progressive decline of her mobility and started to fall out of her armchair, her
family purchased an “armchair lap belt” to prevent the falls. On 19 February 2023 Mrs Lakin slid down
her armchair and under the lap belt, it became caught around her neck and she died as a result.

5

CORONER’S CONCERNS

During the course of the investigation my inquiries revealed matters giving rise to concern. In my
opinion there is a risk that future deaths could occur unless action is taken.
In the circumstances it is
my statutory duty to report to you.

Regulation 28 – After Inquest
Document Template Updated 16/05/2023

 The MATTERS OF CONCERN are as follows:

Pre-amble

Mrs Lakin was a 72 year old female who was diagnosed with Corticobasal Syndrome which caused a
progressive decline in both her mobility and memory. In 2023 Mrs Lakin started to have carers to
support her at home. Her mobility continued to deteriorate and she started to use a wheelchair, she
also started to fall out of bed at night and fall out of her armchair.

Concerned about Mrs Lakin falling out of her armchair her family went onto the internet and found
for sale an “armchair belt” which they purchased on 8 December 2023 and fitted to Mrs Lakin’s
armchair on 9 December 2023. The belt was used without issue until Mrs Lakin died on 19 February
2024.

CCTV cameras captured Mrs Lakin slipping down her armchair and underneath the lap belt which
then becomes caught around her neck. Mrs Lakin was unable to self-rescue by mobilising in the way
that some people might be able to and therefore remained trapped, and effectively suspended by the
lap belt around her neck, until she was found by a family member who visited her. Mrs Lakin died
shortly after she was found.

A post mortem report has confirmed the cause of Mrs Lakin’s death to be 1a) Respiratory
compromise by support belt, 1b) Postural
impairment, 1c) Corticobasal syndrome and atypical
Parkinson’s disease.

Concerns

Mrs Lakin’s family purchased the lap belt with good intentions, they wanted to keep Mrs Lakin safe.

The advertisement and sales particulars for the lap belt that they purchased states “fits any
armchair”, that it provides “extra support to prevent accidents” and finally that it provides “adequate
trunk stability avoiding lateral displacements and slides” and “minimises the chance that the patient
will… suffer any injuries, tilting or slipping”.

The advertisement and sales particulars contain no warning about the risks that are associated with
the use of the lap belt, nor any suggestion that the lap belt should be used or fitted under the
guidance/supervision of a therapist or medical professional.

The evidence heard at the inquest was that the lap belt should be considered a “high risk” piece of
equipment (it is categorised as such in the local NHS Trust’s Standard Operating Procedure) and that
appropriate warnings should be given to those purchasing lap belts in relation to the risks of physical
restraint, tissue viability risks and finally the risk of strangulation.

It is concerning that people who have no healthcare training at all can purchase high risk equipment
for their loved ones online without being appraised of those risks or even being informed about the
high risk nature of the equipment. Lap belts, and other seemingly basic pieces of healthcare
equipment, are readily available for people to purchase online without them being appraised of the
risks that come with the use of the same.

6

ACTION SHOULD BE TAKEN

In my opinion action should be taken to prevent future deaths and I believe you (and/or your
organisation) have the power to take such action.

7

YOUR RESPONSE

Regulation 28 – After Inquest
Document Template Updated 16/05/2023

 You are under a duty to respond to this report within 56 days of the date of this report,
namely by May 30, 2025. I, the coroner, may extend the period.

Your response must contain details of action taken or proposed to be taken, setting out the timetable
for action. Otherwise, you must explain why no action is proposed.
COPIES and PUBLICATION

8

I have sent a copy of my report to the Chief Coroner and to the following Interested Persons

Mrs Lakin’s family
The Leicestershire Partnership NHS Trust
Care at Home (Midlands) Limited
The Care Quality Commission

I have also sent it to

Amazon UK

who may find it useful or of interest.

I am also under a duty to send a copy of your response to the Chief Coroner and all interested
persons who in my opinion should receive it.

I may also send a copy of your response to any person who I believe may find it useful or of interest.

The Chief Coroner may publish either or both in a complete or redacted or summary form. He may
send a copy of this report to any person who he believes may find it useful or of interest.

You may make representations to me, the coroner, at the time of your response about the release or
the publication of your response by the Chief Coroner.

9

Dated: 11/04/2025

Miss I THISTLETHWAITE
His Majesty's Assistant Coroner for Rutland and North Leicestershire

Regulation 28 – After Inquest
Document Template Updated 16/05/2023

Responses

3 responses published against this report on judiciary.uk. A response is a body's written reply to the coroner's concerns; publication is at the discretion of the Chief Coroner's office, so an absent response does not mean nobody replied.

Response from Dhsc (PDF)
From 

Minister of State for Care  

39 Victoria Street  
London  
SW1H 0EU 

24 June 2025 

Our ref: 

HM Assistant Coroner Miss I Thistlethwaite 
HM Coroner’s Office 
Leicestershire County Council 
County Hall 
Glenfield 
Leicestershire   
LE3 8RA 

By email: 

Dear Miss Thistlethwaite,   

Thank you for the Regulation 28 report of  11th April 2025 sent to the Department of 
Health and Social Care about the death of Mrs Susan Marion Lakin. I am replying as 
the Minister with responsibility for adult social care.  

Firstly, I would like to say how saddened I was to read of the circumstances of  Mrs 
Lakin’s  tragic  death,  and  I  offer  my  sincere  condolences  to  her  loved  ones.  The 
circumstances your report describes are very concerning and I am grateful to you for 
bringing these matters to my attention.  

The report raises concerns over the advertisement and sale of the lap belt products 
which led to Mrs Lakin’s death, and the lack of warning and information around the 
dangers that could arise from their use. Officials within the Department of Health and 
Social Care have considered these concerns and concluded that the responsibility for 
these  concerns  sits  within  another  organisation.  I  understand  the  Medicines  and 
Healthcare  products  Regulatory  Agency  (MHRA)  is  also  responding  to  your  report, 
and I hope that their response will be helpful.  

I will be writing to the Office of Product Safety and Standards with my deep concerns 
about the product in question. You may also like to make the  OPSS aware of your 
concerns. 

Thank you for bringing this to my attention.   

Yours sincerely, 

MINISTER OF STATE
Response from Office for Product Safety and Standards (PDF)
Office for Product Safety and Standards 
4th Floor Multistory 
18 The Priory Queensway 
Birmingham 
B4 6BS 

Miss Isobel Thistlethwaite 
HM Assistant Coroner, Rutland and North Leicestershire 
Rutland and North Leicestershire Coroners Court,  
County Hall,  
Glenfield  
LE3 8RA 

6 November 2025 

Dear Miss Thistlethwaite 

I am the Deputy Chief Executive for Regulation at the Office for Product Safety and 
Standards (OPSS), responding to your Prevention of Future Deaths report into the fatality of 
72-year-old Susan Lakin, involving an ORTONES support belt for wheelchairs and 
armchairs. I was very sorry to hear of this tragic fatality, and if you have the opportunity, 
please pass on my condolences to Mrs Lakin’s family.  

As explained in their response to your report, the Medicines and Healthcare products 
Regulatory Agency (MHRA) informed OPSS of this case earlier in the year and shared 
details regarding the circumstances of Mrs Lakin’s death, the product involved and the 
businesses identified. Since being made aware, OPSS has taken a range of actions in 
relation to these and similar products, which I have set out below.  

OPSS has confirmed the position advised by MHRA that the ORTONES Wheelchair and 
Geriatric Armchair Belt Restraint is not in scope of the healthcare products regulatory regime, 
and is instead covered by the General Product Safety Regulations 2005 (the 2005 
Regulations). The 2005 Regulations require businesses to ensure that consumer products 
placed on the UK market are safe, and that potential risks associated with their use have 
been mitigated or reduced as far as possible. This includes by providing appropriate 
instructions for safe use, information about restrictions on use, and any relevant warnings. 
The 2005 Regulations apply where there are not sector specific regulations. 

OPSS can confirm that the relevant businesses (the manufacturer, Eurobaston, and 
Comercial Nespral, the distributor of the product in the UK), have undertaken the following 
corrective action to address the risks posed by the products: 

•  provided updated information in the instructions regarding the product’s potential 
risks, and issued this to customers who had already purchased the product; 
• 
removed the product from sale via Amazon; 
•  withdrawn the product from the UK market.  

The distributor submitted a product notification to OPSS as required by Regulation 9 of the 
GPSR. This publicises the risk posed by the product and the mitigating actions taken by the 
manufacturer.  

These steps should ensure the product is no longer available to purchase in the UK. On 31 
October, OPSS published a product safety report for the ORTONES belt on the Product 

The  Office  for  Product  Safety  and  Standards  (OPSS)  delivers  consumer  protection  and  supports  business 
confidence, productivity and growth. It is part of the Department for Business and Trade. 

gov.uk/opss 

 
 
 
 
 
 
 Recalls and Alerts gov.uk website, to raise awareness of consumers, businesses and other 
regulators to this product’s risks, and the corrective action taken by the business. 

Alongside the steps to reduce the risk to consumers posed by the ORTONES belt, OPSS 
has been gathering wider intelligence into wheelchair/armchair support belt products. There 
is a broad range of similar support belts and harnesses available to UK consumers, supplied 
via online marketplaces and by specialist retailers. This review did not find any evidence of 
product safety concerns raised by Trading Standards or Citizens Advice, and OPSS had not 
received notifications about support belts to our Product Safety Database from other 
regulators. 

However, OPSS noted that the MHRA recorded 29 medical incidents involving these product 
types since 2014, resulting in one fatality and 20 injuries. We also found that the British 
Standards Institution referred to four fatalities in the 15 years prior to introducing the relevant 
product standard BS EN 8625:2019. Further, in our research into similar products available 
on the market today, OPSS established that certain items, intended to aid people who may 
have mobility or strength impairments, were accompanied by instructions for safe use that 
require levels of physical ability that might be beyond people with such impairments. These 
products may not be safe if used without help or supervision, but many products did not carry 
reasonable warnings to raise awareness of, or address, this risk. 

On this basis, OPSS is taking further action on this product category. We have written to 
major online marketplaces, including Amazon, eBay, Temu, Shein and Alibaba, to make 
them aware that certain products may not be provided with suitable instructions or warnings 
to assure safe use by likely users. This will assist online marketplaces to identify whether 
these products are available on their platforms and take action to update or remove relevant 
listings. OPSS has also alerted online marketplaces to our Product Safety Report published 
for the ORTONES belt to make clear this product should not be supplied. OPSS has 
highlighted our activity for these products to relevant stakeholders, including Age UK and the 
Royal Society for the Prevention of Accidents. 

OPSS is continuing to monitor the available evidence and engage with retailers and 
manufacturers in the UK, to ensure products are supplied with clear and appropriate 
instructions and warnings and do not pose a risk when they are used normally and 
foreseeably. 

I hope this information is helpful and provides evidence of OPSS’s commitment to protecting 
consumers, following your Prevention of Future Deaths report into the tragic death of Mrs 
Lakin. I would be grateful, should you have the opportunity, if you would share this with the 
family. 

Kind regards, 

Deputy Chief Executive – Regulation  

Office for Product Safety and Standards 

The  Office  for  Product  Safety  and  Standards  (OPSS)  delivers  consumer  protection  and  supports  business 
confidence, productivity and growth. It is part of the Department for Business and Trade. 

gov.uk/opss
Response from The Medicine and Healthcare Products and Regulatory Agency (PDF)
10 South Colonnade 
Canary Wharf 
London 
E14 4PU 
United Kingdom 
gov.uk/mhra 

Miss I Thistlethwaite  
HM Assistant Coroner  
Rutland and North Leicestershire 
HM Coroner’s Office 
County Hall 
Glenfield 
LE3 8RA 

Reference: 

30 May 2025 

Dear Miss Thistlethwaite, 

Regulation 28: Inquest to investigate the death of Mrs Susan Marion LAKIN.  

We acknowledge your Regulation 28 prevention of future death report, received by MHRA 
on 11 April 2025, relating to the conclusions of the inquest investigating the sad death of 
Susan Marion Lakin. We would like to offer our sincere condolences to her family.  

Your report raises the following concerns: 

•  The sale of Support Belts that contain no warnings in relation to the risks of physical 

restraint, tissue viability risks and finally the risk of strangulation. 

•  The sale of Support Belts that contain no suggestion that the product should be used 

or fitted under the guidance/supervision of a therapist or medical professional. 

•  Support Belts, and other seemingly basic pieces of healthcare equipment, are readily 
available for people to purchase online without them being appraised of the risks that 
come with their use. 

I have taken the opportunity to provide you with some supporting information below, before 
providing comments to your matters of concern. 

 
 
 
 
 
 
 
 
  
 
 
 
 
 The Medicines and Healthcare products Regulatory Agency (MHRA) is an executive agency 
of the Department of Health and Social Care (“DHSC”). We are the regulator of medicines, 
medical devices and blood components for transfusion in the UK.  

With  respect  to  medical  devices,  one  major  area  of  the  MHRA’s  responsibilities  is  the 
investigation of adverse incidents. An adverse incident is an event involving a medical device, 
which  produces,  or  has  the  potential  to  produce,  unwanted  effects  involving  the  safety  of 
patients, users and other persons. 

The MHRA operates a voluntary reporting scheme, called the Yellow Card scheme 1, where 
health professionals and members of the public can report adverse incidents to us directly. 
Additionally,  manufacturers  of  medical  devices  are  required  to  report  details  of  all  serious 
incidents involving medical devices to the MHRA as part of their mandatory vigilance reporting.  

Where  serious  incidents  involving  medical  devices  have  been  reported  to  other  authorities 
including the police and coroners, the MHRA provides input if required. The MHRA will then 
ensure any concerns raised from these investigations, if required, are disseminated to either 
healthcare  professionals  directly  or  to  healthcare  institutions  to  help  to  prevent  further 
incidents and take up the concerns directly with the manufacturer of the medical device. 

Manufacturers placing a medical device on the market are required to identify the potential 
hazards associated with the use of the medical device, evaluate the related risks and 
eliminate or reduce these risks as far as possible; finally users of the device must be 
informed of any residual risks. Manufacturers are expected to follow the principles set out in 
BS EN ISO 14971:2019+A11:2021 Medical devices - Application of risk management to 
medical devices. This approach aims to also ensure that any new risks are incorporated into 
risk management process therefore facilitating ongoing improvement throughout the 
product’s lifecycle. 

Manufacturers should also demonstrate how their devices meet the relevant 
Designated/Harmonized Standards. If they have not applied these standards, then they must 
provide a description of the solutions adopted to fulfil the requirements which apply to the 
devices.  This information should be included within their technical documentation for 
the devices. 

It is important to note that the MHRA does not conduct inspections of medical devices, nor 
do we directly authorise or certify medical devices for placement onto the market. However, 
all medical devices are required to be registered with the MHRA prior to selling them in the 
UK. 

Each  medical  device  is  assigned  a  classification  (I,  IIa,  IIb  or  III)  based  largely  upon  its 
considered  “risk”  factor  to  the  patient  according  to  medical  device  classification  rules  in 
the Medical Devices Regulations 2002 (SI 2002 No 618, as amended) (UK MDR 2002)2. To 
place  a  medical  device  on  the  market,  manufacturers  must  obtain  certification  that 
demonstrates their conformity to the regulatory requirements 3. This certification is represented 
as a CE or UKCA mark and is displayed on the medical device itself. To gain CE or UKCA 

1 Yellow Card | Making medicines and medical devices safer (mhra.gov.uk) 
2 The Medical Devices Regulations 2002 (legislation.gov.uk) 
3 Regulating medical devices in the UK - GOV.UK (www.gov.uk) 

 
 
 
 
 
 
 
 
 
 marking,  the  higher  risk  (class  IIa,  IIb  and  III)  devices  need  to  be  certified  by  an  approved 
conformity assessment body. Whereas manufacturers of the lowest risk/class devices (class 
I) self-certify against the requirements in relevant legislation. 4 

Background 

In April 2015 the MHRA released Medical Device Alert (MDA/2015/018), for all posture or 
safety belts fitted to supportive seating5. The Alert stated, “Using the wrong type of belt or a 
belt that isn’t fitted or adjusted properly can lead to serious injury or death of the person 
using the equipment.” 

The Alert goes on to explain that all users and carers need to have received training on how 
to check, adjust, clean, and maintain each device; and individuals need to be reviewed to 
check that the right type of belt is used and adjusted correctly. 

Finally, the alert clarifies that the problems associated with these devices include “the person 
in the seat slipping down and suffering positional asphyxiation or strangulation...”. The 
targeted audience was those involved in the provision, prescription, use and maintenance of 
the belts and it was cascaded through the Central Alerting System (CAS). This was 
withdrawn in 2022 as the number of reports had reduced to zero and the actions should 
have been incorporated into good practice within the NHS. 

Action undertaken by MHRA to date 

Establishment of the appropriate Regulator 
On receipt of the regulation 28 letter we sought further confirmation that the support belt 
purchased by Mrs Lakin’s family was the ORTONES Wheelchair and Geriatric Armchair Belt 
Restraint, reference D2100 (henceforth referred to the ORTONES belt).  

Through our investigations, the manufacturer Eurobaston S.L, confirmed that the ORTONES 
belt is marketed as a class I medical device in Spain, however they had not registered the 
ORTONES belt with the MHRA, which is a legal requirement for all medical devices sold in 
the UK. They informed us that they were unaware that their distributor, Comercial Nespral 
S.L, was selling the product in the UK. Comercial Nespral S.L, has confirmed that the 
ORTONES belt is no longer marketed in the UK.  

The MHRA’s Borderline team have reviewed the intended use and claims of the ORTONES 
belt and concluded that wheelchair belts are unlikely to meet the definition of a medical 
device in their own right, as the intended purpose is to prevent accidents and falls, which is 
not considered to be a medical purpose.  

We also considered whether the belt would meet the definition of an accessory to a medical 
device. An “accessory” to a medical device, as defined by regulation 5(1) of the UK MDR, 
means a product which, whilst not itself a medical device, is intended specifically by its 
manufacturer to be used together with a medical device, to enable that device to be used in 
accordance with its intended use. Wheelchair belts are considered accessories if they are 
specifically designed by the manufacturer for use in conjunction with a specific wheelchair, 

4 Guidance on Class I medical devices - GOV.UK (www.gov.uk) 
5 Medical Device Alert 

 
 
 
 
 
 
 
 
 
 
 
 and the manufacturer of the wheelchair has evidenced in their instructions for use that their 
wheelchair cannot fulfil its intended purpose without the belt.  

In considering the Instructions for Use for the ORTONES belt (Annex A), we do not consider 
it would be classified as an accessory to a medical device based on the following: 

1.  There are no claims that the belt is intended to be used with a specific wheelchair  
2.  The belt seems to be designed for general use as it is also promoted for use on non-

medical products (armchairs) 

3.  The intended use is stated to provide “maximum support and safety: It is designed to 
bring maximum comfort to the user of a wheelchair. Provides extra support to prevent 
accidents and falls”, which is not a medical purpose 

It is worth noting that in the UK, not all products which are used in a healthcare environment, 
by a disabled person, or by a healthcare professional or carer, qualify as medical devices. 

It should be noted that wheelchairs may come already supplied with a belt, and in these 
cases, the belt is a component of the wheelchair and the wheelchair as a whole, including 
the belt, is regulated as a medical device. 

In addition to the concerns regarding the ORTONES belt, we have identified several other 
supportive belts that are sold online that do not appear to be registered with the MHRA. 
However, they also make general claims, similar to the ORTONES belt, and are therefore 
unlikely to qualify as medical devices or accessories to a medical device. 

Given this, the MHRA has advised the relevant regulator, the Office of Product Safety and 
Standards (OPSS), to ensure that they are aware of your concerns.  

Warnings. 
We have reviewed the ISO standard for Selection, placement and fixation of flexible postural 
support devices in seating (part 15 of the wheelchair seating series): ISO/TS 16840‑15:2024. 
The purpose of this standard is to specify the criteria to be applied to positioning supports 
when used in seating systems and chairs. 

According to ISO/TS 16840‑15:2024, flexible postural support devices (PSD) shall be 
prescribed for safety when the primary purpose is to protect the occupant from 
injury (e.g. to prevent falling from the seat), and occupants should be assessed as to the 
correct style and size of PSD to be prescribed. The standard also covers the safety 
information to be included in the user instructions for use; for example “any special 
requirements as to who can prescribe and fit a postural support”, the “need for any periodic 
checking the occupant’s skin for associated pressure injuries” and “the risks of strangulation 
due to poor positioning”. 

The MHRA reviewed the instructions for use for the ORTONES belt (see attached 
document). While they did not contain the warnings required in the standard, as the belt is 
not considered a medical device or accessory to a medical device, addressing this is outside 
the MHRA’s remit. However, this information will be highlighted to OPSS as the relevant 
regulator.  

Prevalence of the problem 

 
 
 
 
 
 
 
 
 
 
 
 There are many other supportive belt devices that are registered with the MHRA as medical 
devices. We reviewed the MHRA’s adverse incident database for cases involving support 
belts that were reported to us between 1 April 2015 to 23 April 2025 following the release of 
the alert in 2015. The broad device code ‘Wheelchair accessory’ was used in the search, 
which includes types of wheelchair/chair/stander occupant restraint/support devices.  

This search generated 398 reports, twenty-nine (29) of which specifically detailed the use of 
a support belt, one of which resulted in a fatality. See Table 1 for a breakdown of these 
incident reports.  

Table 1: Breakdown of reported incidence reports  

Incident themes 

Total number of reports 

User slipping under the support belt 
resulting in an injury 

Three (3) 

Reported year of 
incident* 
One  in 2017 
One in 2016 
One in 2018 

One in 2014 
Two in 2015 
Two in 2016 
Two in 2017 
One in 2018 
One in 2023 
One in 2016 
One in 2017 
One in 2023 
Three in 2015 
One in 2016 
One in 2018 
Three in 2024 
One in 2025 

Nine (9) 

Three (3) 

Nine (9) 

Failure of postural support, or the 
unbuckling/detachment of the belt 
leading to a fall 

Belt not fastened appropriately - 
resulting in a fall 

Failure of postural support where the 
belt had either become loose, 
unbuckled or detached/broken (no 
injury reported) 

Report raising a safety concern 
relating to support belts namely misuse 
of belts and lack of guidance 

User misunderstanding the belt’s fitting 
instructions 

Two (2) 

Two in 2015 

One (1) 

One in 2017 

Exposure of a sharp edge of the belt - 
resulting in an injury (cut on hand) 

Two (2) 

One in 2015 
One in 2023 

Total: Twenty nine (29) 

* Where the date of incident has not been provided, the date of the report has been used. 

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 Twenty-two (22) out of twenty-nine (29) reported incidents took place between 2014 and 
2018. We note that Mrs Lakin’s case had not been reported to us prior to receiving the 
Regulation 28 report, and recognise that adverse incident reports for products not regulated 
as medical devices, would not be reported to the MHRA. 

Further action to be undertaken by MHRA 

Eurobaston S.L has committed to the re-evaluation of the ORTONES belt design, labelling 
and instructions for use. Eurobaston S.L have informed us that they will be working with 
Comercial Nespral S.L to determine what corrective actions can be implemented for 
ORTONES belts that have been distributed in the UK.  
The MHRA will inform OPSS of this ongoing investigation into the sale of support belts 
without the appropriate warnings, including the ORTONES belt. In addition, we will include 
OPSS in our communications with the Eurobaston S.L, to assess the appropriateness of 
their corrective actions. 

Any wheelchair belts which would fall under the definition of a medical device or accessory 
and are not registered with the MHRA will be referred to the MHRA’s compliance team. 

Conclusion 

Pending the conclusion of the investigation and actions detailed above, we will continue to 
monitor all adverse incidence reports we receive and take any necessary action as 
appropriate.   

Yours sincerely, 

Chief Safety Officer 

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 Annex A – Instructions For Use for the ORTONES belt 

 
 MANUAL / INSTRUCCIONES
GEBRAUCHSANWEISUNG / INSTRUCTIONS / ISTRUZIONI

REF: D2100

REF: F5-AWH

REF: D2101

REF: D2104

WHEELCHAIR BELT/CINTURON SILLA DE RUEDAS/ROLLSTUHLGURT/CEINTURE POUR FAUTEUIL ROULANT/CINTURA PER SEDIA A ROTELLE

D2101

D2100

F5-AWH

D2104

EN 

D2100

F5-AWH2

D2101

D2104

CODE

ES

D2100

F5-AWH2

D2101

D2104

REFERENCIA

WHEELCHAIR BELT
The  Abdominal  belt  has  maximum  support  and  safety:  It  is  designed  to  provide  maximum  comfort  to  the  user  of  a 
wheelchair, geriatric chair or armchair. It provides extra support to prevent accidents and falls. It minimises the possibility 
of the patient falling and suffering injuries, tipping or slipping.

CINTURON SILLA DE RUEDAS
El cinturón Abdominal tiene máxima sujeción y seguridad: Está diseñado para conseguir aportar la comodidad máxima 
al usuario de una Silla de Ruedas, Silla Geriátrica o Sillón. Aporta una sujeción extra para prevenir accidentes y caídas. 
Reduce al mínimo la posibilidad de que el paciente se caiga y pueda sufrir lesiones, se ladee o se resbale.

INDICATIONS FOR USE
Suitable for people with reduced mobility, wheelchair and geriatric chair users, who require extra support to prevent falls 
and fronto-lateral slipping in a seated position.
The belts must be adjusted to the user's anatomy, so that they are tight enough to effectively hold the user in the chair, 
but not too tight to avoid injuries or lacerations.
For this purpose, the length of the fastening straps has to be adjusted in advance by means of the movable adjustment 
of the locking part of the plastic trident. The belt should be fastened at the back of the backrest of the wheelchair so that 
the user is secured to the backrest.
In the case of the perineal straps, pass the lower strap through the perineal area between the thighs. On the back side 
of the backrest, join both ends of the abdominal straps by means of a locking system, tightening both straps until the 
desired fastening is obtained, then fasten the perineal strap and adjust it.

INDICACIONES DE USO
Indicado para personas con movilidad reducida, usuarios de silla de ruedas y sillón geriátrico, que requieran un extra de 
sujeción para evitar caídas y deslizamientos fronto-laterales en posición de sedestación.
Los cinturones se han de ajustar a la anatomía del usuario, de forma que queden lo suficientemente ajustados para que 
lo sujeten efectivamente a la silla, pero no demasiado apretados para evitar lesiones o laceraciones.
Para ello, se ha de regular previamente la longitud de las cinchas de sujeción mediante el ajuste móvil de la parte del 
cierre del tridente de plástico. El cierre del cinturón se ha de realizar por la parte posterior del respaldo de la silla de 
forma que el usuario quede sujeto al mismo.
En  el  caso  de  los  perineales,  pase  la  cincha  inferior  por  la  zona  perineal  entre  los  muslos.  Por  la  cara  posterior  del 
respaldo una ambos extremos de las cinchas abdominales mediante sistema de cierre tensando ambas cinchas hasta 
obtener la sujeción deseada, seguidamente fije la cincha perineal procediendo a su ajuste.

FEATURES
■ Dimensions: 

CARACTERÍSTICAS
■ Dimensiones: 

PRODUCT

DIMENSIONS

LENGTH 
Including grip straps

MATERIAL

LOCK

PRODUCTO

DIMENSIONES

LONGITUD
Incluyendo cintas agarre

MATERIAL

CIERRE

D2100

F5-AWH2

D2101

D2104

45 x 15 cm

160 cm / 63 inches

Nylon cordura and Suede 

Trident closure

D2100

45 x 15 cm

45 x 15 cm

300 cm / 118 inches

Nylon cordura and Suede 

Trident closure

F5-AWH2

45 x 15 cm

45 x 15 cm

160 cm / 63 inches

Nylon cordura and Suede 

Trident closure

45 x 15 cm

300 cm / 118 inches

Nylon cordura and Suede 

Magnetic closure

D2101

D2104

45 x 15 cm

45 x 15 cm

160 cm

300 cm

160 cm

300 cm

Nylon cordura y Antelina

Cierre de tridente

Nylon cordura y Antelina

Cierre de tridente

Nylon cordura y Antelina

Cierre de tridente

Nylon cordura y Antelina

Cierre magnético

CLEANING AND DISINFECTION
■  Clean only with water and neutral soap. It is not recommended to use: chlorine, bleach, disinfectants with alcohol 

LIMPIEZA Y DESINFECCIÓN
■  Limpiar  solo  con  agua  y  jabón  neutro.  Está  desaconsejado  utilizar:  cloro,  lejía,  desinfectantes  con  alcohol  o 

or abrasive products.

productos abrasivos.

■  We recommend to pre-washed a small surface area be when using hospital cleaning products.
■  Never use drying presses, the waterproof layer can be broken by not letting the water molecules out.
■  Do not iron.
■  Machine washable, maximum 30°. Allow to dry at room temperature.

■  Se  recomienda  realizar  un  test  previo  de  lavado  en  una  pequeña  superficie  cuando  se  utilicen  productos 

limpiadores de hospitales.

■  Nunca utilizar prensas de secado, se puede romper la capa impermeable al no dejar salir las moléculas de agua.
■  No planchar.
■  Lavable a máquina, máximo 30°. Dejar secar a temperatura ambiente.

    WARNINGS!
■  Caustic products, paint strippers, solvents and sharp objects in direct contact with the belt are prohibited.
■  Regularly inspect the belt for normal wear and tear: holes, cracks and fastening system.
■  Store belts preferably in a flat position and protected from natural light and humidity.
■  Do not burn or throw away in the wild, outside of the designated areas.
■  The guarantee will remain in force for 3 years from the date of the consumer's original purchase. This warranty 

does not cover normal wear and tear of the product and does not replace legal warranties.

    ¡ADVERTENCIAS!
■  Están prohibidos los productos cáusticos, decapantes, disolventes y objetos punzantes o cortantes en contacto 

directo con el cinturón.

■  Examinar regularmente el desgaste normal del cinturón: orificios, grietas y sistema de cierre. 
■  Almacenar los cinturones preferentemente en posición plana y protegidos de la luz natural y de la humedad.
■  No quemar ni tirar en la naturaleza, fuera de los lugares destinados para ello.
■  La garantía permanecerá vigente durante 3 años desde la fecha de compra original del consumidor. Esta garantía 

■  Please  observe  the  care  and  maintenance  instructions.  The  manufacturer  assumes  no  liability  for  damage 

no cubre el desgaste normal del producto y no sustituye a las garantías legales.

resulting from improper care or maintenance.

■  Tenga en cuenta las instrucciones de cuidado y mantenimiento. El fabricante no asume ninguna responsabilidad 

■  Please contact the company in the event of a problem to resolve it.
■  This does not affect your legal rights.
■  Please keep these instructions for future reference.
■  According to the manufacturer's recommendations this product is suitable for recycling.
■  Any serious incident related to the product must be reported to the manufacturer and the competent authority of 

por los daños derivados de un cuidado o mantenimiento incorrectos.

■  Se ruega contactar con la empresa en caso de incidencia para resolverla.
■  Conserve estas instrucciones para referencias futuras.
■  Según las recomendaciones del fabricante este producto es adecuado para su reciclaje.
■  Cualquier incidente grave relacionado con el producto debe notificarse al fabricante y a la autoridad competente 

the Member State in which the user and patient are established.

del Estado miembro en el que estén establecidos el usuario y el paciente.

This product is NOT intended for reuse by several persons and any modification to this product not expressly authorised 
by  the  manufacturer  shall  exempt  the  manufacturer  from  any  liability  arising  from  its  use.  As  well  as  the  use  of  this 
garment for a purpose other than that for which it was manufactured.

Este  producto  NO  ha  sido  diseñado  para  ser  reutilizado  por  varias  personas  y  cualquier  modificación  que  se  realice 
sobre el mismo que no haya sido expresamente autorizada por el fabricante eximirá a éste de cualquier responsabilidad 
que pueda derivarse de su utilización. Así como del uso de esta prenda con un fin distinto para el cual fue fabricado.

FABRICADO POR:

DISTRIBUIDO POR:

EUROBASTÓN S.L.
Polígono de Promosa Cl. w5, nave 7
33211 Gijón, Asturias

COMERCIAL NESPRAL S.L.
Linares Rivas, 6, ent. dcha.
33206 Gijón, Asturias
www.comercialnespral.com

30º

 DE

D2100

F5-AWH2

D2101

D2104

dejavel, des désinfectants à base d'alcool ou des produits abrasifs.

REFERENZEN

NETTOYAGE ET DÉSINFECTION
■  Nettoyez  uniquement  avec  de  l'eau  et  du  savon  neutre.  Il  n'est  pas  recommandé  d'utiliser  :  du  chlore,  de  l'eau 

ROLLSTUHLGURT
Der Bauchgurt bietet maximalen Halt und Sicherheit: Er ist so konzipiert, dass er dem Benutzer eines Rollstuhls, eines 
geriatrischen Stuhls oder eines Sessels maximalen Komfort bietet. Er bietet zusätzlichen Halt, um Unfälle und Stürze zu 
vermeiden. Er minimiert die Möglichkeit, dass der Patient stürzt und sich Verletzungen zuzieht, kippt oder ausrutscht.

ANWENDUNGSGEBIETE
Geeignet  für  Personen  mit  eingeschränkter  Mobilität,  Rollstuhlfahrer  und  geriatrische  Patienten,  die  zusätzliche 
Unterstützung benötigen, um Stürze und ein Ausrutschen im Sitzen zu verhindern.
Die Gurte müssen an die Anatomie des Benutzers angepasst werden, so dass sie eng genug sind, um den Benutzer 
effektiv im Stuhl zu halten, aber nicht zu eng, um Verletzungen oder Schnittwunden zu vermeiden.
Zu  diesem  Zweck  muss  die  Länge  der  Befestigungsgurte  im  Voraus  mit  Hilfe  der  beweglichen  Einstellung  des 
Verschlussteils  des  Kunststoffdreizacks  angepasst  werden.  Der  Gurt  sollte  an  der  Rückseite  der  Rückenlehne  des 
Rollstuhls befestigt werden, damit der Benutzer an der Rückenlehne gesichert ist.
Bei den Dammgurten ist der untere Gurt durch den Dammbereich zwischen den Oberschenkeln zu führen. Verbinden 
Sie auf der Rückseite der Rückenlehne die beiden Enden der Bauchgurte mit Hilfe eines Verschlusssystems und ziehen 
Sie beide Gurte fest, bis die gewünschte Befestigung erreicht ist; befestigen Sie dann den Dammgurt und stellen Sie ihn 
ein.

FEATURES
■ Abmessungen: 

PRODUKT

ABMESSUNGEN

LÄNGE
Einschliesslich griffschlaufen

MATERIAL

SCHLIESSSYSTEM

■  Nous  recommandons  un  test  de  prélavage  sur  une  petite  surface  lors  de  l'utilisation  de  produits  de  nettoyage 

hospitaliers.

■  N'utilisez  jamais  de  presse  à  sécher,  la  couche  imperméable  peut  être  brisée  en  ne  laissant  pas  sortir  les 

molécules d'eau.
■  Ne pas repasser.

    AVERTISSEMENTS!
■  Les produits caustiques, les décapants, les solvants et les objets tranchants ou coupants en contact direct avec 

la ceinture sont interdits.

■  Contrôler régulièrement l'usure normale de la ceinture : trous, fissures et système de fixation. 
■  Stocker les courroies de préférence à plat et à l'abri de la lumière naturelle et de l'humidité.
■  Ne pas brûler ou jeter dans la nature, en dehors des zones prévues à cet effet.
■  La garantie est valable 3 ans à compter de la date d'achat initial par le consommateur. Cette garantie ne couvre 

pas l'usure normale du produit et ne remplace pas les garanties légales.

■  Veuillez  respecter  les  instructions  d'entretien  et  de  maintenance.  Le  fabricant  n'assume  aucune  responsabilité 

pour les dommages résultant d'un entretien ou d'une maintenance inappropriés.

■  Veuillez contacter l'entreprise en cas de problème pour le résoudre.
■  Conservez ces instructions pour toute référence ultérieure.
■  Selon les recommandations du fabricant, ce produit peut être recyclé.
■  Tout incident grave impliquant le produit doit être signalé au fabricant et à l'autorité compétente de l'État membre 

où l'utilisateur et le patient sont établis.

Ce  produit  n'est  PAS  destiné  à  être  réutilisé  par  plusieurs  personnes  et  toute  modification  de  ce  produit  non 
expressément autorisée par le fabricant exonère ce dernier de toute responsabilité liée à son utilisation. De même que 
l'utilisation de ce vêtement dans un but autre que celui pour lequel il a été fabriqué.

D2100

45 x 15 cm

F5-AWH2

45 x 15 cm

45 x 15 cm

D2101

D2104

160 cms

300 cms

160 cm

Nyloncord und Wildleder

Druckschloss

Nyloncord und Wildleder

Druckschloss

Nyloncord und Wildleder

Druckschloss

45 x 15 cm

300 cm

Nyloncord und Wildleder

Magnetischer
Verschluss

IT

D2100

F5-AWH2

D2101

D2104

REFERENZA

REINIGUNG UND DESINFEKTION
■  Wir empfehlen eine kleine Fläche zum Testen der Putzmittel zu verwenden, wenn Sie mit Krankenhausprodukte-

narbeiten.

■  Pressen Sie das Produkt nicht zum Trocknen, da dadurch die wasserdichte Schicht gebrochen werden kann.
■  Nicht bügeln.

    WARNHINWEISE!
■  Ätzende Produkte, Abbeizmittel, Lösungsmittel und scharfe oder schneidende Gegenstände in direktem Kontakt 

mit dem Band sind verboten.

■  Kontrollieren Sie den Gurt regelmäßig auf normale Abnutzung: Löcher, Risse und Befestigungssystem. 
■  Lagern Sie die Riemen vorzugsweise flach und vor natürlichem Licht und Feuchtigkeit geschützt.
■  Nicht verbrennen oder in der freien Natur entsorgen, außerhalb der dafür vorgesehenen Bereiche.
■  Die  Garantie  gilt  für  3  Jahre  ab  dem  Datum  des  ursprünglichen  Kaufs  durch  den  Verbraucher.  Diese  Garantie 

deckt nicht den normalen Verschleiß des Produkts ab und ersetzt nicht die gesetzlichen Gewährleistungen.

■  Bitte beachten Sie die Pflege- und Wartungshinweise. Der Hersteller übernimmt keine Haftung für Schäden, die 

durch unsachgemäße Pflege oder Wartung entstehen.

■  Bei Problemen wenden Sie sich bitte an das Unternehmen, um diese zu beheben.
■  Bewahren Sie diese Anleitung zum späteren Nachschlagen auf.
■  Gemäß den Empfehlungen des Herstellers ist dieses Produkt für das Recycling geeignet.
■  Jeder  schwerwiegende  Zwischenfall  mit  dem  Produkt  muss  dem  Hersteller  und  der  zuständigen  Behörde  des 

Mitgliedstaates, in dem der Benutzer und der Patient ansässig sind, gemeldet werden.

Dieses Produkt ist NICHT zur Wiederverwendung durch mehrere Personen bestimmt, und jede nicht ausdrücklich vom 
Hersteller genehmigte Änderung an diesem Produkt entbindet den Hersteller von jeglicher Haftung, die sich aus seiner 
Verwendung ergibt. Gleiches gilt für die Verwendung dieses Kleidungsstücks für einen anderen Zweck als den, für den 
es hergestellt wurde.

FR

D2100

F5-AWH2

D2101

D2104

REFÉRÉNCE

CEINTURE POUR FAUTEUIL ROULANT
La ceinture abdominale offre un maximum de soutien et de sécurité : elle est conçue pour offrir un maximum de confort 
à l'utilisateur d'un fauteuil roulant, d'une chaise gériatrique ou d'un fauteuil. Elle offre un soutien supplémentaire pour 
prévenir les accidents et les chutes. Elle minimise les risques de chute et de blessure, de basculement ou de glissement 
du patient.

INDICATIONS D'UTILISATION
Convient  aux  personnes  à  mobilité  réduite,  aux  utilisateurs  de  fauteuils  roulants  et  de  chaises  gériatriques,  qui  ont 
besoin d'un soutien supplémentaire pour prévenir les chutes et les glissements fronto-latéraux en position assise.
Les  ceintures  doivent  être  ajustées  à  l'anatomie  de  l'utilisateur,  de  sorte  qu'elles  soient  suffisamment  serrées  pour 
maintenir efficacement l'utilisateur dans le fauteuil, mais pas trop pour éviter les blessures ou les lacérations.
À cette fin, la longueur des sangles de fixation doit être réglée à l'avance au moyen de l'ajustement mobile de la partie 
de verrouillage du trident en plastique. La ceinture doit être fixée à l'arrière du dossier du fauteuil roulant de manière à 
ce que l'utilisateur soit attaché au dossier.
Dans le cas des sangles périnéales, passez la sangle inférieure dans la zone périnéale entre les cuisses. Sur la face 
arrière  du  dossier,  joindre  les  deux  extrémités  des  sangles  abdominales  au  moyen  d'un  système  de  verrouillage,  en 
serrant les deux sangles jusqu'à obtenir la fixation souhaitée, puis fixer la sangle périnéale et l'ajuster.

FONCTIONNALITÉS
■ Dimensions: 

PRODUIT

DIMENSIONS

LONGUEUR  Compris les
sangles de préhension

MATÉRIEL

FERMETURE

D2100

45 x 15 cm

F5-AWH2

45 x 15 cm

160 cms

300 cms

Nylon sain d'esprit et Suède

Fermoir trident

Nylon sain d'esprit et Suède

Fermoir trident

D2101

D2104

45 x 15 cm

160 cm

Nylon sain d'esprit et Suède

Fermoir trident

45 x 15 cm

300 cm

Nylon sain d'esprit et Suède

Fermeture
magnétique

CINTURA PER SEDIA A ROTELLE
La cintura addominale offre il massimo sostegno e sicurezza: è progettata per offrire il massimo comfort all'utente di una 
sedia a rotelle, di una sedia geriatrica o di una poltrona. Fornisce un sostegno supplementare per prevenire incidenti e 
cadute. Riduce al minimo la possibilità che il paziente cada e subisca lesioni, si ribalti o scivoli.

INDICAZIONI PER L'USO
Indicato per persone con mobilità ridotta, utenti di sedie a rotelle e poltrone geriatriche, che necessitano di un supporto 
extra per prevenire cadute e scivolamenti fronto-laterali in posizione seduta.
Le cinture devono essere regolate in base all'anatomia dell'utente, in modo che siano sufficientemente strette per tenere 
efficacemente l'utente sulla sedia, ma non troppo per evitare lesioni o lacerazioni.
A tal fine, la lunghezza delle cinghie di fissaggio deve essere regolata in anticipo mediante la regolazione mobile della 
parte di bloccaggio del tridente di plastica. La cintura deve essere fissata sul retro dello schienale della carrozzina in 
modo che l'utente sia assicurato allo schienale.
Nel  caso  delle  cinghie  perineali,  far  passare  la  cinghia  inferiore  attraverso  l'area  perineale  tra  le  cosce.  Sul  lato 
posteriore dello schienale, unire le due estremità delle cinghie addominali mediante un sistema di bloccaggio, stringendo 
entrambe le cinghie fino a ottenere il fissaggio desiderato, quindi allacciare la cinghia perineale e regolarla.

CARATTERISTICHE
■ Dimensioni: 

PRODOTTO

DIMENSIONI

LUNGHEZZA
Comprese le cinghie di presa

MATERIALE

CHIUSURA

D2100

45 x 15 cm

F5-AWH2

45 x 15 cm

D2101

D2104

45 x 15 cm

45 x 15 cm

160 cm

300 cm

160 cm

300 cm

Nylon cordura e Camoscio

Chiusura a tridente

Nylon cordura e Camoscio

Chiusura a tridente

Nylon cordura e Camoscio

Chiusura a tridente

Nylon cordura e Camoscio

Chiusura magnetica

PULIZIA E DISINFEZIONE
■  Pulire solo con acqua e sapone neutro. Si sconsiglia l'uso di: cloro, candeggina, disinfettanti con alcool o prodotti 

abrasivi.

■  Si consiglia di prelavare una piccola superficie quando si utilizzano prodotti per la pulizia ospedaliera.
■  Non  utilizzare  mai  presse  essiccanti,  lo  strato  impermeabile  può  essere  rotto  non  lasciando  uscire  le 

molecoled'acqua.

■  Non stirare.
■  Lavabile in lavatrice, massimo 30°. Lasciare asciugare a temperatura ambiente.

    AVVERTENZE!
■  Sono vietati prodotti caustici, sverniciatori, solventi e oggetti taglienti o affilati a diretto contatto con il nastro.
■  Ispezionare regolarmente il cintura per verificarne la normale usura: fori, crepe e sistema di fissaggio. 
■  Conservare i cinture preferibilmente in posizione piana e al riparo dalla luce naturale e dall'umidità.
■  Non bruciare o gettare in natura, al di fuori delle aree designate.
■  La garanzia rimarrà in vigore per 3 anni dalla data di acquisto originale del consumatore. Questa garanzia non 

copre la normale usura del prodotto e non sostituisce le garanzie legali.

■  Osservare le istruzioni per la cura e la manutenzione. Il produttore non si assume alcuna responsabilità per danni 

derivanti da una cura o manutenzione impropria.

■  Si prega di contattare il reparto qualità dell'azienda in caso di problemi per risolverli.
■  Ciò non pregiudica i vostri diritti legali.
■  Si prega di conservare queste istruzioni per riferimento futuro.
■  Secondo le raccomandazioni del produttore questo prodotto è adatto al riciclaggio.
■  Qualsiasi incidente grave relativo al prodotto deve essere se gnalato al produttore e all'autorità competente dello 

Stato membro in cui sono stabiliti l'utente e il paziente.

Questo prodotto NON è stato progettato per essere riutilizzato da più persone e qualsiasi modifica apportata allo stesso 
che non sia stata espressamente autorizzata dal produttore esonera quest'ultimo da qualsiasi responsabilità che possa 
derivare dal suo utilizzo. Così come l'uso di questo indumento per uno scopo diverso da quello per cui è stato fabbricato.

FABRICADO POR:

DISTRIBUIDO POR:

EUROBASTÓN S.L.
Polígono de Promosa Cl. w5, nave 7
33211 Gijón, Asturias

COMERCIAL NESPRAL S.L.
Linares Rivas, 6, ent. dcha.
33206 Gijón, Asturias
www.comercialnespral.com

30º

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