Prevention of Future Deaths reports · 2025

Philip Jones

Regulation 28 report to prevent future deaths, reference 2025-0111, written 27 Feb 2025. A coroner writes one of these when an inquest reveals a risk that could cause further deaths unless something changes.

Date of report27 Feb 2025
Reference2025-0111
DeceasedPhilip Jones
CoronerRichard Middleton
Coroner areaDorset
CategoryProduct related deaths
Sourcejudiciary.uk record · original PDF
Responses published2

The report

Text recovered by OCR from a scanned PDF. OCR is imperfect: check anything you rely on against the source PDF. Reproduced verbatim, including the scan's own layout.

REGULATION 28: REPORT TO PREVENT FUTURE DEATHS (1)

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

REGULATION 28 REPORT TO PREVENT FUTURE DEATHS
THIS REPORT IS BEING SENT TO:

1. CEO of Fixodent
2. Care Quality Commission

1 | CORONER

I am Richard T Middleton, Assistant Coroner, for the Coroner Area of Dorset

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 the 5 july 2024, an investigation was commenced into the death of
Philip Leslie Jones, born on the 15 September 1931.

The investigation concluded at the end of the Inquest on the 20" February
2025.

The Medical Cause of Death was:
1 (a) Hypoxic brain injury

(b) Choking
(c) Inhalation of adhesive gel

2. Dementia
The conclusion of the Inquest recorded

Accident

4 | CIRCUMSTANCES OF THE DEATH

In August 2022 Mr Jones was diagnosed with dementia and on 6/9/22 he took
up residence at a care home which specialised in such care. On 23/6/24 a
member of staff found Mr Jones in his room with denture adhesive gel in his
mouth, ears and nose. Attempts were made to remove the substance from his
mouth. Mr Jones’ breathing became laboured and paramedics attended and
took him to hospital where his health deteriorated and he died on 23/6/24.

RONER‘

ERNS

The MATTERS OF CONCERN are as follows:

1. During

vi.

vii.

vill.

2. Ihave

the inquest evidence was heard that:

Mr Jones lived in a self-contained unit at the care home where he
had his own room and en suite facilities.

Upon his arrival risk assessments were carried out including
choking hazards and a full Care Plan created which included oral
care.

Although Mr Jones was living with dementia, he was able to care
for himself except for being prompted and with the support from
one care staff with his personal care.

He had capacity to make daily non-complex decisions. He wished

to maintain his independence as far as possible with all aspects
of his daily care needs. He was able to manage elements of his
own daily personal care which included oral care.

Mr Jones had upper and lower dentures which he secured in
place on a daily basis using an adhesive gel. He had daily access
to this gel which was stored in his bathroom cabinet. There were
no reported concerns regarding his daily access to the adhesive
gel. The gel and other toiletries were provided by his family.

When paramedics attended on 23/6/24 they attempted to
remove the gel with a suction machine but were unsuccessful.

At autopsy there was evidence of upper airway obstruction by
thick adhesive gel. This thick adhesive gel was seen inside the
mouth and pharynx and had completely blocked the larynx and
trachea and extended into the left bronchus

The packaging of the gel was examined and there was no
warning on either the box or the enclosed leaflet that gave a
warning that the gel was a potential choking hazard.

concerns with regard to the following:

The choking risk which this product poses. The qualities of the
product are such that a thick adhesive gel can become lodged
deep into the respiratory system and can be extremely difficult to
remove

Such a product is likely to be used by the older generation and
those who may be suffering from a decline of brain functioning.

iii Such a product should be considered as part of any risk
assessment for those living in a care home setting.

iv. There is no warning on the product packaging or on the enclosed
information leaflet as to the risk of choking.

ACTION SHOULD BE TAKEN

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

YOUR RESPONSE

You are under a duty to respond to this report within 56 days of the date of this
report namely by 24" April 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

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

(1) Mr Jones’ Family
(2) Southbourne Beach Care Home

I am also under a duty to send the Chief Coroner a copy of your response.

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.

Dated Signed

\

\
\}

Richard T Middleton

27" February 2025 /< may _—

Responses

2 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 Cqc (PDF)
REPORT BY JEMMA CIEROCKI

TO HM CORONER

IN RESPECT OF THE INQUEST OF PHILLIP LESLIE JONES

In the first instance, please extend our condolences to Mr Jones’ loved ones, we understand this
would have been incredibly distressing for them.

Mr Jones was living with a diagnosis of dementia prior to his passing. CQC expects registered
providers to ensure care and support is delivered in a way that manages risk, whilst balancing this
with a person’s independence. After an assessment of his needs, Mr Jones continued to manage his
oral healthcare independently. Fixodent was stored in Mr Jones’ bathroom for him to use and there
were no previous known occasions when Mr Jones had ingested this. As I am sure you are aware,
CQC has specific criminal enforcement powers when avoidable harm has occurred, or when a service
user has been exposed to a significant risk of such harm occurring. Due to the circumstances of Mr
Jones’ passing, we reviewed the incident in line with our specific incident guidance. This was to
establish whether there were failings in care that could have been attributed to a registered
person/provider failure. In summary, we found Mr Jones’ death was not the result of avoidable harm
resulting from a registered person/provider failure.

The provider has investigated the circumstances of Mr Jones’ passing. In summary, the findings
conclude that, while there was no specific risk assessment regarding the management of Fixodent,
Mr Jones had been safely managing his oral health care, and Fixodent use, since his admission to the
service in 2022. As part of the aforementioned investigation, the provider had reviewed lessons
learned. Actions planned by the provider included the organisational sharing of information about
the circumstances of Mr Jones’s passing, to raise awareness. Additionally, identifying residents who
use denture adhesive products, or similar, with a view to reviewing documentation and safety
measures. Although we believe these adhesive gels are not considered medical devices and are thus
not under MHRA’s remit, they may be able to assist with further communications to raise awareness
of the risk with the product manufacturers.

I note you have requested the Chief Executive Officer (CEO) of Fixodent should consider placing a
warning on packaging so it is clear that ingestion of the product is a potential risk. It is important to
consider brands beyond just Fixodent (the CEO of which is listed as the other named respondent in
the Regulation 28 report). There are several brands of denture adhesive gel available which will
potentially carry the same choking risk due to the substance consistency. The patient safety leaflets
of two popular brands of denture adhesive were reviewed and neither contained choking as a
hazard, though they do advise what to do in the event of ingesting or inhaling. It is not within the
CQC’s remit to raise this issue with the CEOs of these companies, so further action may be required
by HM Coroner and/or the Office for Product Safety and Standards.

In terms of action that will be taken by CQC, it is recommended that this incident should be featured
as an issue on CQC’s Learning from safety incidents webpage. This would help raise awareness and
share the learning with providers to help prevent similar incidents in the future. This webpage
should reference:

 Risks relating to denture adhesive gel (as a product generically – there are multiple brands on
the market)



Advise providers to consider denture adhesive gel in the following risk assessments:

 Health and Safety Executive’s COSHH Risk Assessment, in accordance with the Control of

Substances Hazardous to Health Regulations 2002.











Risk assessments carried out relating to the health, safety and welfare of people using
services, in accordance with Regulation 12: Safe care and treatment - Care Quality
Commission. Individualised risk assessment and care planning that should already be
taking place should ensure vulnerable people are identified and protected.

Remind providers of the existing expectation that they should undertake a risk
assessment for oral health in line with NICE guidance.

Advise providers to consider in care planning:

There are also different types of denture adhesives – strips, powder and creams – which
can be used to secure dentures and should be considered on a case-by-case basis.

Existing guidance relating to dementia and oral health, such as is featured on this
webpage dementia UK.

Operations Manager
Response from Procter and Gamble UK (PDF)
Richard T. Middleton 
Assistant Coroner 
Dorset Area Coroners 

Procter & Gamble UK 
The Heights, Brooklands, 
Weybridge, Surrey,  
KT13 0XP 
+44 (0) 1932 896000 phone 
+44 (0) 1932 896200 fax 
www.uk.pg.com 

22nd April 2025 

Re: Regulation 28 Prevention of Future Death in respect of Mr. Philip Leslie Jones 

Dear Mr. Middleton, 

We wish to begin by expressing our heartfelt condolences to the family and friends of Mr. Philip Leslie Jones in light of 
the  tragic  circumstances  surrounding  his  passing.  We  recognise  the  gravity  of  the  issues  highlighted  in  the  Coroner’s 
Prevention of Future Deaths report and appreciate the chance to respond.  

Our  commitment  to  safety  is  unwavering.  We  rigorously  assess  the  safety  of  all  our  ingredients  and  finished  products 
before they are introduced, employing well-established risk assessment methods to evaluate potential hazards including 
choking  and  potential  exposures.  These  evaluations  are  integral  to  our  product  development  process   starting  from  the 
early  design  stages  and  continuing  after  the  products  are  made  available  on  the  market.  Ensuring  the  safety  of  our 
products,  packaging,  and  operations  for  our  employees,  consumers  and  the  environment  is  a  fundamental  aspect  of 
conducting responsible business and is crucial for building and maintaining public trust.  

It is important to clarify that Fixodent products fully comply with EU and UK medical device regulations. We provide 
clear  usage  instructions  on  the  product,  its  packaging  and  the  accompanying  leaflet.  They  are  safe  and  do  not  pose  a 
choking risk when used as intended and directed, as supported by Mr. Jones's previous experience with denture adhesive 
cream.  

Our  commitment  to  consumer  safety  is  evident  in our  comprehensive  post -market  surveillance  system  which  monitors 
any adverse events related to our products. This proactive approach aims to prevent future incidents and enhance overall 
consumer safety. The data from our surveillance system confirms that the product is safe with clear usage instructions.  

We  acknowledge  and  respect  the  Coroners’  perspective  that  this  product  should  be  considered  in  risk  assessments  for 
individuals living in care home settings. We also believe that  all products, not just oral care items, should be included in 
initial and regular risk assessments for those living with dementia in care home settings. On the day of his death , it was 
reported that denture adhesive cream was found in Mr. Jones’s ears and nose indicating that the product was not used as 
intended which is crucial for understanding this incident. 

Given these considerations, we are not proposing changes to our product or its packaging at this time. We will continue 
to monitor any adverse events related to the product to ensure its ongoing safety. 

Thank  you  for  allowing  us  to  address  these  concerns.  We  remain  committed  to  ensuring  the  safety  and  well -being  of 
those who use our products and once again extend our deepest sympathies to Mr. Jones' family and friends.  

Yours sincerely, on behalf of Fixodent 

Senior Communications Director 

Procter & Gamble UK, a partnership between Procter & Gamble (L&CP) Limited, registered in England and Wales under Company No. 3288185, and Procter & Gamble (Health & 
Beauty Care) Limited, registered in England and Wales under Company No. 436549.  The Heights, Brooklands, Weybridge, Surrey, KT13 0XP.

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