Prevention of Future Deaths reports · 2018

Sylvia Mitchell

Regulation 28 report to prevent future deaths, reference 2018-0383, written 5 Dec 2018. A coroner writes one of these when an inquest reveals a risk that could cause further deaths unless something changes.

Date of report5 Dec 2018
Reference2018-0383
DeceasedSylvia Mitchell
CoronerZafar Siddique
Coroner areaBlack Country
CategoryHospital Death (Clinical Procedures and medical management) related deaths · Community health care and emergency services 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  

REGULATION 28 REPORT TO PREVENT FUTURE DEATHS 

THIS REPORT IS BEING SENT TO: 

1.  Chief Executive, Sandwell and West Birmingham Hospitals NHS Trust. 
 Medical Centre, 199 Shady Lane, Birmingham, B44 9ER  
2. 

1 

CORONER 

I am Zafar Siddique, Senior Coroner, for the coroner area of the Black Country. 

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 June 2018, I commenced an investigation into the death of Mrs Sylvia Mitchell. 
The  investigation  concluded  at  the  end  of  the  inquest  on  27  November  2018.  The 
conclusion of the inquest was a narrative conclusion of: 

Died  after  developing  a  rare  but  recognised  complication  of  urosepsis  after  failures  to 
adequately  monitor  and  review  a  patient  with  a  shelf  pessary  which  had  become 
impacted  and  resulted  in  a  recto-vagino-vesical  fistula.    These  failures  to  review  more 
than  minimally,  negligibly  or  trivially  contributed  to  the  death  and  neglect  as  rider  is 
added to this narrative conclusion.  

The cause of death was:   

1a     Urosepsis 
  b 
  c   
II Chronic Degenerative Mitral & Aortic Valvar Disease. Nephrolithiasia 

Recto-Vagino-Vesical Fistula(impacted Gellhorn Pessary) 

4 

CIRCUMSTANCES OF THE DEATH 

i)  Mrs  Mitchell  was  a  90  year  old  woman  with  a  previous  medical  history  of 
osteoarthritis and also bladder prolapse.  She was managed conservatively 
for the latter condition initially with a ring pessary between December 1999 
and Aril 2008.  During this period the pessary was regularly changed.  

ii)  From April 2008 onwards a new replacement Gelhorn pessary was issued.  
This was then reviewed in June but she failed to attend her appointment in 
September  and  did  not  then  re-attend  gynaecology  services  until  6  March 
2013 when her GP referred her back. 

iii)  She then attended the outpatient clinic and an impacted shelf pessary was 
found.  This required a surgical procedure under anaesthetic to be removed. 

iv)  She  was  then  booked  in  for  a  pre-operative  assessment  but  developed 

1 

[IL1: PROTECT] 

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 MRSA and the procedure postponed to January 2014.  However she didn't 
attend this appointment due to illness. A further letter was sent by the Trust 
to her GP and to the patient to advise when she was fit to be seen again. 
The GP and patient don’t have any record of this. 

v) 

It  wasn't  until  1  August  2016  that  a  further  appointment  had  been 
rescheduled.  However, the patient cancelled this appointment.  

vi)  She  had  a  number  of  Hospital  admissions  in  2017  including  an  admission 
on  the  29  October  2017  when  she  was  diagnosed  with  urosepsis.    She 
recovered and was discharged in December.  Her condition declined further 
and she was readmitted to Hospital on the 21 May 2018 and sadly she died 
on the 23 May 2018 at Good Hope Hospital.  

5 

CORONER’S CONCERNS 

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

The MATTERS OF CONCERN are as follows.  –  

1.  Evidence emerged during the inquest that there was inadequate communication 
between  the  Trust  and  GP  advising  Mrs  Mitchell  of  the  risks  of  not  having  the 
pessary removed urgently. 

2.  Specifically,  the  Pathologist  gave  evidence  confirming  that  pessaries  are 
typically used in the non-surgical management of severe pelvic organ prolapse, 
often  in  post-menopausal  women  with  poorly  oestrogenised,  and  easily 
traumatised  vaginal  mucosa.  A  pessary  is  a  foreign  object  in  constant  contact 
with  the  vaginal  epithelium,  therefore,  its  use  requires  adequate  follow-up  to 
ensure  proper  fitting,  routine  cleansing  and  monitoring  of  the  integrity  of  the 
vagina.  Failure  to  observe  these  precautions  heightens  risk  of  infection, 
impaction/incarceration  and  ulceration,  potentially  with  recto-vaginal  and/or 
vesico-vaginal  fistulation  –  the  latter  are  very  rare  iatrogenic  complications  of 
pessary  use  with  only  approximately  8  cases  reported  in  the  world  literature 
(Gordon  GH  et  al.  J  Clin  Gynecol  Obstet.  2015;  4  (1):  193-196),  almost 
exclusively,  however,  associated  with  Gellhorn  and  shelf  pattern  prostheses, 
usually  in  the  age  range  of  70  to  80  years,  often  allegedly  contributed  to  by 
lapse of regular maintenance & hygiene procedures.  

3.  Due to the delays in removal of the pessary she died as a result of developing a 

fistula and urosepsis. 

6 

ACTION SHOULD BE TAKEN 

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

1.  The Trust may wish to consider urgently reviewing the patients who maybe in a 
similar  position  and  have  failed  to  have  any  follow  up  review  of  the  Gellhorn 
Pessary.  

2.  The GP Practice may wish to consider adding all patients to their list of patients 
with  a  pessary  (either  ring  or  Gellhorn)  to  ensure  that  adequate  referral  to 
gynaecology services occurs.

2 

[IL1: PROTECT] 

 
 
 
 
 
 
 
 
 
 
 
 
 3.  To  assist 

I  have  attached  a  similar  PFD  report  and 
responses/audit performed by another Trust within the Black Country area. 

the  Trust, 

the 

7 

YOUR RESPONSE 

You are under a duty to respond to this report within 56 days of the date of this report, 
namely by 1 February 2018. 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. 

8 

COPIES and PUBLICATION 

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

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. 

9 

 5 December 2018                                                   

Mr Zafar Siddique
Senior Coroner 
Black Country Area 

3 

[IL1: PROTECT]

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 Oaks Medical Centre (PDF)
Oaks
Medical Centre

199 Shady Lane
Great Barr
Birmingham
B44 9ER

1 19 Chester Road
Streetly
Sutton Coldfield
B74 2HE

www.oaksmedical.net

Please send all correspondence to Shady Lane address

12 September 2018

Black Country Coroners Court
Jack Judge House
Oldbury
B69 2AJ

Dear Sirs

Re:

D.O.B.: 02  March 1928

I am 
for the past 28 years and  have the following qualifications:

, senior partner at the Oaks Medical Practice. I have been a GP

Bachelor of  Medicine, Bachelor of  Surgery (Leicester University 1984)
Member of  the Royal College of  General Practitioners: (Edinburgh 1989)
Diploma of  the Royal College of  Obstetricians and  Gynaecologists
Diploma of  Community Child  Health
Diploma of  Palliative Medicine

I am  writing on  behalf  of  the practice as 

 left the Practice on 1st May 2017.

was a patient of  the practice registered with  us from 13 th December 1966.

She was on the following regular medication:
Cavilon Durable barrier cream (3M  Health Care  Ltd) 2 gram - use as directed
Adcal-D3 Dissolve 1500mg/400unit effervescent tablets (Kyowa Kirin Ltd) 28 tablet - take
one daily
Aendronic acid 70mg tablets 4 tablet - take one  weekly Administrative Notes: As per
discharge summary 17.11.17
Aspirin 75mg dispersible tablets 28 tablet - take one daily
Macrogol compound oral  powder sachets NPF sugar free 1 20 sachet - 2 sachets twice a day
Administrative Notes: Ad per discharge summary 17.11.17
Paracetamol 500mg tablets 224 tablet - take 2 tablets four times a day
Senna 7.5mg tablets 56 tablet - take 2 at night
Amoxicillin 250mg capsules 28 capsule - 1 EVERY  DAY
Splenectomy NEC (78403)
Gaviscon Advance Mint chewable tablets (Reckitt Benckiser Healthcare (UK) Ltd) 28 tablet
- ASD, Mint
Fortisip Compact liquid strawberry (Nutricia Ltd) 15000 ml - 1 twice daily

 
 I have known 
to her unfortunate death.

since 12th April  1991. 1 was the last Doctor to have visited 

prior

Over the years she has become increasingly frail and  became bedbound by 6th October 2017.
When I saw her at home  with her son  present with a swelling of  her left elbow. This was
investigated with blood tests which were found to be acceptable and  was treated with
Naproxen and Omeprazole (this was stopped on  17th October 2017 following a telephone call
as her elbow was better).

Last contact was with her son on 22 nd March 201 8 in order to continue her nutritional
support.

On  looking at her records
1 . 

was called by City  Hospital for removal of  her pessary in December 2013  but this

was cancelled by the patient as she was  not feeling well. Following this 
(who also left the Practice on 1st November 2017) carried out a telephone call  with her
son and  noticed that the ring pessary had  not  been changed since 2013, a referral was
carried out on that day and an appointment was made on 1st August 2016.  We have had
no further correspondence regarding this referral.

2.  She  was seen on 13 th February 2017 by 

(currently on leave, returning on 25th

September 2018 ) who carried out a home visit with her son present, as carer’s had
noticed a pessary coming out.  He noted that she has a pessary for vaginal prolapse, on
examination the abdomen was soft  non-tender and  inspection of  vulva and  introitus - no
vaginal prolapse seen, no pessary seen. 
son and
agreed as he cannot see a pessary coming out today or a vaginal prolapse, to wait and see.
Advice was given to the son that if  carer’s notice the pessary again, to contact us to refer
to Gynaecology.

 had a discussion with 

3.  Looking through the records her last admission prior to 21 May 2018 was 29 th October
2017 for Urosepsis secondary to “L”ureteric calculus, further investigation was not
deemed  possible due to patient frailty.

4.  There were no further assessments by the GPs at the Practice.
5.  There was an assessment for nutritional support on 30th November 2017.

I believe the contents of  this statement are true and  to the  best of  my knowledge.

It is with great sadness that the practice heard of  her untimely death and  I would  like to
convey our deepest sympathy at this sad time on  behalf  of  the Oaks Medical Practice. I had
dealt closely with 
strong Patient -  G.P. relationship.

and  her son for many  years and developed what  I thought was a

Yours sincerely

Diabetes Care.
Practice Code -
Response from Sandwell and West Birmingham Hospital NHS Trust (PDF)
Sandwell and West Birmingham Hospitals
NHS Trust

NHS

DEPARTMENT OF OBSTETRICS & GYNAECOLOGY

City Hospital
Dudley Road
Birmingham
B18 7QH

RECEIVED  M 

M f <

31 December 2013

The Oaks Medical Centre
669 Kings Rd, Great Barr
Birmingham
B44 9HU

Dear Dr Naik

Re: Ms Sylvia Mitchell DOB: 02 Mar 1928 NHS Number: 488 827 9446 (01)
129 DUNEDIN ROAD GREAT BARR BIRMINGHAM B44 9DL

} 

,i

il

The above named lady has been sent 2 appointments to come in to hospital to have her ring pessary
removed.  However, she cancelled her last appointment with me as she did not feel well enough to come in
I 
I would be grateful if you could let me know when Sylvia feels ready to come in to hospital for her procedure
and I would be more than happy to send her a new date.

,,

Consultant in Obstetrics & Gynaecology

it 
Please do not call the medical secretaries for test results as this information can not be given over
the telephone 

■  - - -

ir- — 

J

Private & Confidential
Copy to:
Ms Sylvia Mitchell
129 DUNEDIN ROAD
GREAT BARR
B44 9DL

A University of  Birmingham Teaching Hospital

CWZ34601

MITCHELL, Sylvia (Ms), printed 04 Mar 2026 12:54 (page 1 of 1)

 Oaks
Medical Centre

1 99 Shady Lane 
Great  Barr 
Birmingham 
B44 9ER 

1 1 9 Chester Road
Streetly
Sutton Coldfield
B74 2HE

FAX:  0121366 6977 

www.oaksmedical.net

Please send all correspondence to Shady Lane address

01 Jul 2016

Ms Sylvia Mitchell
129 Dunedin  Road
Great  Barr
Birmingham
B44 9DL

Dear Ms Mitchell

Further to your recent consultation with 
Appointment Details.

, please find attached choose and  book

An appointment has been  booked for you as per Section 2 on the form.

If  you wish to change this appointment please follow the  instructions in Section 3.

Your password can  be found on the back  page.

Many thanks.

Yours sincerely,

Dictated but  not  signed

Oaks  Medical Centre
Response from Sandwell and West Birmingham NHS Trust (PDF)
Mr Z Siddique 
H.M.Coroner 
Black Country Coroner’s Court 
Jack Judge House 
Oldbury 
West Midlands 
B69 2AJ 

June 2nd 2019 

Dear Mr Siddique 

RE: Regulation 28 Report – Sylvia Mitchell 

I am in receipt of your Regulation 28 Report following the Inquest and your ruling on 27 November 
2018, in respect of the late Mrs Sylvia Mitchell.  It has taken too long to then reply to you, but we 
have in truth been working on this issue in the intervening time, and debating the implications 
with clinical colleagues including GP leaders.  Your finding clearly has implications for all 
disciplines. 

In respect of Mrs Mitchell, I do believe that we attempted to review her at appropriate intervals 
and listed her for surgery to remove the pessary. Unfortunately she was unwell and unable to 
attend on the date organised and we requested that both the patient and the GP let us know 
when she was well enough to undergo surgery. As you know, this did not occur.  We apply NHS-
standard protocols for the ‘chasing’ of patients in these circumstances.   

Every person attending for pessary insertion now receives an information leaflet which clearly 
outlines the need for follow up appointments and the risks of having a pessary, including 
ulceration, bleeding and discharge.  These are being translated into multiple languages.  We will 
share these leaflets with primary care colleagues for provision in consult rooms locally. 

In addition, we had already amended our processes to tighten further our follow up procedure. 
Women self-book their 6 monthly appointments via partial booking, but if this does not happen 
we follow up with a letter. For women who do not attend for a planned appointment, we send a 
further appointment for 4 weeks’ time. This is repeated should they fail to attend again and then 
will write to the GP requesting them to review and let us know if a further appointment is 
required.  We have now asked our Planned Care Board to undertake a twice yearly clinical review 
of any patient who does not reply to all of those efforts.  This list, pseudo-anonymised, will also be 
provided to Primary Care Network colleagues.  In other words we will be more overtly curious 
about the reasons for non-response. 

As part of this, looking forward patients who we have identified have not had a follow up as 
planned are being recalled for a review appointment with our Clinical Nurse Specialists. We are 
also discussing ways to enable us to easily see which women need follow up, and when this need 

 
 
 
 ceases, either because the pessary has fallen out, is no longer required for personal or alternative 
treatment reasons. 

You asked us to ensure that any patients who may have missed opportunities to be seen, as Mrs 
Mitchell was, are safe and this is in progress and will likely continue through this year. I am 
satisfied that we have a process in place which is recalling women appropriately and that we are 
developing further ways to identify those women who need following up in our service, rather 
than with their GP, to give a further safety net. 

In six months’ time we will review at the Trust’s Board data on non-responders within gynaecology 
services for the prior 18 months to see if there are any further omissions we might consider. 

My colleague, 
advice or further details on our actions, or indeed updates on the progress moving forward.

, Deputy Director of Governance, would be best placed to provide 

Yours sincerely 

Chief Executive 

cc. 

 Family of Mrs Mitchell 

, Clinical Chair, Sandwell and West Birmingham CCG 

, Group Director, Women and Child Health 

, Deputy Chief Operating Officer

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