Source · Prevention of Future Deaths

Philip Jones

Ref: 2025-0111 Date: 27 Feb 2025 Coroner: Richard Middleton Area: Dorset 2 responses identified · 2 indexed addressees View PDF

AI-generated concerns summaryThe coroner identified concerns about the choking risk from a thick dental adhesive gel, particularly for older users and those with cognitive decline, as it can be difficult to remove. There is no warning about this hazard on the product packaging or leaflet.

Date 27 Feb 2025

56-day deadline 24 Apr 2025 est. estimated from the report date

Responses identified 2 of 2

Product related deaths

Coroner's concerns

AI summary

The coroner identified concerns about the choking risk from a thick dental adhesive gel, particularly for older users and those with cognitive decline, as it can be difficult to remove. There is no warning about this hazard on the product packaging or leaflet.

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During the inquest evidence was heard that: Mr Jones lived in a self-contained unit at care home where he had his own room and en suite facilities: ii Upon his arrival risk assessments were carried out including choking hazards and a full Care Plan created which included oral care:
iii. 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:
iv. 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. V. Mr Jones had upper and lower dentures which he secured in place on 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 The gel and other toiletries were provided by his family.
vi. When paramedics attended on 23/6/24 attempted to remove the gel with a suction machine but were unsuccessful;
vii. At autopsy there was evidence of upper airway obstruction by thick adhesive 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 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 ii_ Such product is likely to be used by the older generation and those who be suffering from a decline of brain functioning: the gel: they gel:
viii. have may iii . Such 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:

Responses

2 respondents

Procter and Gamble UK

Letter dated 22 Apr 2025 PDF

AI-classified response stance Noted

AI-generated response summary

• Procter and Gamble UK stated that Fixodent products comply with EU and UK medical device regulations and include clear usage instructions. • The company stated it rigorously assesses product safety, including potential choking hazards, and maintains a comprehensive post-market surveillance system. • Procter and Gamble UK stated it is not proposing changes to the product or its packaging at this time.

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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.

CQC

Regulator / Inspectorate

PDF

AI-classified response stance Action Planned

AI-generated response summary

• The CQC will feature this incident on its Learning from safety incidents webpage to raise awareness among providers. • The CQC will advise providers to consider denture adhesive gel in COSHH and Regulation 12 risk assessments. • The CQC will remind providers to undertake oral health risk assessments in line with NICE guidance and consider denture adhesives in care planning.

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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

Report sections

Investigation and inquest

On the Sth July 2024, an investigation was commenced into the death of Leslie Jones, born on the 15th September 1931 The investigation concluded at the end of the Inquest on the 20th February 2025_ The Medical Cause of Death was: 1 (a) Hypoxic brain injury (b) Choking Inhalation of adhesive gel
2. Dementia The conclusion of the Inquest recorded Accident

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 ad 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. 28: Philip

Action should be taken

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

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Report details

Reference: 2025-0111
Date of report: 27 February 2025
Coroner: Richard Middleton
Coroner area: Dorset

Responses identified

Responses identified 2 of 2

All listed responses identified

Organisations named in PFD reports are normally expected to respond within 56 days. Deadline: 24 Apr 2025 (estimated from the report date).

Sent to

Care Quality Commission

Fixodent

Part of a series

2 reports

2022-0255 All responses identified

Source links

Judiciary.uk page → Report PDF →

Data: judiciary.uk.

Contains public sector information licensed under the Open Government Licence v3.0.