Product related deaths

PFD Category
Reports: 131 Areas: 54 Earliest: Oct 2013 Latest: 5 Aug 2025

77% response rate (above 63% average). 31% of classified responses show concrete action taken. Reports rose 150% from 6 (2023) to 15 (2024).

PFD Reports
131 results
Helena Opuku
Historic (No Identified Response)
2021-0341 12 Oct 2021 East London
Department of Health and Social Care London Borough of Redbridge
Concerns summary (AI summary) Social services struggled to properly investigate safeguarding referrals, appoint social workers within a reasonable timeframe, or conduct timely home suitability assessments for vulnerable residents.
Aaron Fretwell
All Responded
2021-0331 5 Oct 2021 West Yorkshire (East)
Bailey Trailers Ltd
Concerns summary (AI summary) An agricultural trailer lacked a required propping device and warning signs, failing to meet safety regulations. Many similar trailers remain in use without these critical safety features, posing a risk of future accidents.
Action Taken (AI summary) The company now fits a mechanical body support to secure the body in a high position during maintenance to all applicable trailers; its revised operation and maintenance manual states how to deploy it and warns users to never work under a raised body unless propped, and has emailed dealers to explain the design does not require the trailer to be raised for routine maintenance.
Mary Land
All Responded
2021-0322 29 Sep 2021 West Yorkshire (East)
Department of Health and Social Care Mid Yorkshire Hospitals NHS Trust Philips Respironics
Concerns summary (AI summary) The Philips Respironics AF 541 mask uses an insecure 'push-on' connection to the ventilator, prone to detaching, especially with a filter. A more robust docking mechanism is needed to prevent inadvertent disconnections.
Disputed (AI summary) The Mid Yorkshire Hospitals NHS Trust has already completed four actions identified in an RCA investigation, including scoping improvements for securing tubing circuit connections. They continue to use filters per BTS guidance, and note the manufacturer is addressing all-in-one circuit availability. The MHRA will agree an investigation plan with Philips Respironics, engage with them on standards compliance, and discuss updating guidance with the British Thoracic Society and NICE. They will also continue to assess incoming data and take action as needed. Philips Respironics argues that the AF541 mask design meets standards, is not intended to prevent disconnection, and is contraindicated for life support. They state the facility failed to follow instructions and incorrectly used an unapproved filter, leading to the incident, therefore no action is proposed. The Department of Health and Social Care acknowledges the MHRA's actions, including requesting a final investigation report from Phillips Respironics and discussions with the British Thoracic Society and NICE on updated guidance. It also mentions the Care Quality Commission (CQC) is monitoring the Mid Yorkshire Hospitals NHS Trust action plan.
Antony Schofield
All Responded
2021-0324 27 Sep 2021 Manchester City
Greater Manchester Mental Health NHS Tr…
Concerns summary (AI summary) Inadequate risk assessments, poor communication during patient transfer, and a lack of professional curiosity by community mental health staff led to missed opportunities to address escalating suicidal risk, compounded by poor audit and flawed investigation.
Action Taken (AI summary) Greater Manchester Mental Health NHS Foundation Trust has updated its process for obtaining staff statements following a Serious Incident, and has addressed factual inaccuracies with the RCA investigation author. They ensure all Serious Incidents are reviewed by a team supported by a Patient Safety Practitioner and that the final draft is shared with senior managers.
William Buchanan
All Responded
2021-0300 1 Sep 2021 Dorset
Department of Health and Social Care
Concerns summary (AI summary) Elderly individuals can acquire mobility scooters without any assessment of their suitability or competence to use them, posing a significant safety risk.
Noted (AI summary) The Department for BEIS acknowledges the report but asserts that existing product safety regulations are adequate for mobility scooters. They argue that placing an obligation on individuals to undertake an assessment before purchasing specific products would be disproportionate and propose that no further action is taken.
Ann Geraghty
All Responded
2021-0288 27 Aug 2021 Birmingham and Solihull
Philips Electronics UK Ltd
Concerns summary (AI summary) Cardiac monitors' alarms self-terminate upon rhythm correction, failing to alert staff to serious, self-resolving events like ventricular standstill, and the manufacturer has not provided a solution.
Disputed (AI summary) Philips Healthcare investigated the reported incident and concluded that the device operated per specification, that there is not a configuration available to enable asystole or any other red arrhythmia alarm to self-terminate, and that termination of asystole or other red arrythmia alarm with the current configuration requires end user intervention. University Hospitals Birmingham NHS Foundation Trust will provide refresher training to nursing staff on the alarm systems, explore altering the software configuration with Philips, and explore the retention of trace logs locally for an extended period.
Pauline Allison
All Responded
2021-0269 3 Aug 2021 West Sussex
British Medical Association and Sussex …
Concerns summary (AI summary) Insufficient awareness among patients, families, and carers about the increased fire risk from flammable emollient creams, especially when combined with air mattresses, poses a significant safety concern.
Noted (AI summary) NHS Brighton & Hove CCG, NHS East Sussex CCG, and NHS West Sussex CCG have reviewed preventable deaths messaging related to flammable products and are raising awareness of the risks from emollient creams, including publishing warnings and providing information to GPs, care homes, and patients about the fire risks associated with these products, based on previous alerts from the MHRA. The BMA acknowledges the concern about patient awareness of risks associated with emollient creams, but states they are not the appropriate organisation to address it. They suggest contacting the MHRA, NHS England, the Royal College of General Practitioners, and medical defence bodies instead.
Andrew Cook
All Responded
2021-0258 18 Jun 2021 Northamptonshire
Medicines and Healthcare products Regul…
Concerns summary (AI summary) Concerns involve potential under-reporting of PEG allergy, insufficient research into its effects, and the lack of clear labelling on medical products regarding PEG's presence, dose, and various synonyms.
Action Planned (AI summary) The MHRA will discuss labelling requirements with other regulators internationally, collect and review information from a range of data sources on PEG exposure, and raise the profile of PEG/macrogol working with relevant stakeholders where appropriate.
Emiel Malinski
All Responded
2021-0198 10 Jun 2021 Manchester South
Home Office
Concerns summary (AI summary) Miniature rifle ranges operate with minimal regulation, lacking essential safety measures such as secure weapon tethering, competent supervision, ammunition control, and first aid provisions.
Action Planned (AI summary) The Home Office is reviewing the firearms licensing exemption for miniature rifle ranges, prompted by the incident. They conducted a public consultation on tightening controls and will consider the responses before deciding on further measures.
Nicholas O’Brien
All Responded
2021-0197 9 Jun 2021 Hampshire, Portsmouth and Southhampton
British Kite Surfing Association
Concerns summary (AI summary) A kite-surfing radio device adhered to a helmet failed to detach when entangled, preventing depowering and leading to a fatal dragging incident. The device's attachment method was insecure, posing risks for similar helmet-mounted accessories.
Action Taken (AI summary) The British Kitesports Association issued recommendations to schools using BB-Talkin headsets or similar devices, including following manufacturer's instructions, checking equipment, making students aware of potential entanglement, and including guidelines in their Safety Management Systems.
Shane Gilmer
Historic (No Identified Response)
2021-0140 5 May 2021 County of the East Riding of Yorkshire and City of Kingston-Upon-Hull
Home Office
Concerns summary (AI summary) Crossbows lack essential regulation, including ownership records or licensing, unlike firearms. This absence of control over their circulation and storage, despite their lethal capabilities, poses a significant public safety risk.
Peter Hussey
All Responded
2021-0115 19 Apr 2021 Stoke-on-Trent & North Staffordshire Coroner’s Court
Enteral (GB) UK, University Hospital of… MHRA NHS Supply Chain
Concerns summary (AI summary) An enteral feeding and drainage tube's product description and staff training were insufficient, leading to confusion about its reduced bore size. This caused inadequate drainage, and the product is still misleadingly promoted.
Action Planned (AI summary) NHS England and Improvement are working with the Healthcare Safety Investigation Branch (HSIB) testing and introducing national patient safety incident investigation training and developing a patient safety incident investigation training procurement framework. GBUK Enteral Ltd has revised device labelling and Instructions For Use (IFU) to remove references to drainage, add warnings about flow restrictions with ENFit connectors, and clarify the intended use as a feeding tube. They have also provided refresher training to sales staff and requested NHS supply chain to update the device description on their website. The Trust has designed a new proforma for evaluating equipment and has updated the Trust e-learning training package for the insertion and on-going management of Nasogastric/Orogastric tubes including troubleshooting guidance and a competency and self-assessment document. The manufacturer has updated the product labelling for the Carefeed devices to remove the secondary intended use of drainage; MHRA will write to UK manufacturers of nasogastric tubes to advise them of the risk associated with the use of the ISO standard ENFit connector in aspiration/decompression situations and ask them to update their risk assessment and is collaborating with NHS England and Improvement on raising awareness on the Medical Devices Safety Officers' (MDSO) network.
Stephen Oakes
All Responded
2021-0114 19 Apr 2021 Stoke-on-Trent & North Staffordshire Coroner’s Court
Enteral (GB) UK, University Hospital of… Industry Groups Supply Chain Stakeholders
Concerns summary (AI summary) Product description for a 14Fr feeding/drainage tube was misleading due to a restrictive connector, leading to inadequate drainage. Hospital evaluation was insufficient, and staff lacked training on product changes and alternative actions.
Action Planned (AI summary) The manufacturer has updated the product labelling for the Carefeed devices to remove the secondary intended use of drainage; MHRA will write to UK manufacturers of nasogastric tubes to advise them of the risk associated with the use of the ISO standard ENFit connector in aspiration/decompression situations and ask them to update their risk assessment and is collaborating with NHS England and Improvement on raising awareness on the Medical Devices Safety Officers' (MDSO) network. GBUK has revised device labelling and instructions for use, removing all references to drainage and adding warnings about flow restrictions with ENFit connectors and has provided refresher training to its sales force regarding nasogastric feeding tubes and ENFit connectors. The Trust has designed a new proforma for evaluating equipment and has updated the Trust e-learning training package for the insertion and on-going management of Nasogastric/Orogastric tubes including troubleshooting guidance and a competency and self-assessment document. NHS England and Improvement are working with the Healthcare Safety Investigation Branch (HSIB) testing and introducing national patient safety incident investigation training and developing a patient safety incident investigation training procurement framework.
Nicholas Winterton
Partially Responded
2021-0204 31 Mar 2021 City of London
College of Clinical Perfusion Scientists National Institute for Cardiovascular O… Public Health England +1 more
Concerns summary (AI summary) The nationally recognized risk level for Mycobacterium Chimaera infection is inaccurate and outdated, leading to inadequate informed consent and a low threshold of suspicion among clinicians.
Action Planned (AI summary) PHE will update risk estimates for Mycobacterium chimaera infection and publish them by September 2021, cascading the information to healthcare professionals through clinical networks; they will forward the request to update NHS guidance to NHS England.
Lynn Hadley
All Responded
2021-0346 18 Jan 2021 Black Country Area
Medicines and Healthcare Products Regul…
Concerns summary (AI summary) Oxygen cylinder regulators present an ignition risk, possibly due to incorrect valve operation by paramedics lacking knowledge of safety protocols, with multiple reported incidents despite no identified device defects.
Noted (AI summary) West Midlands Ambulance Service took immediate action by informing all frontline staff of requirements for medical gas cylinder assembly/disassembly and sharing lessons learned with partner organizations. The CQC acknowledges the concerns but states it is outside of their remit to issue or change formal guidance or policies around oxygen usage or safety, as they are not clinical experts. They will continue to communicate with WMAS and monitor actions taken to improve safety. HSE will support MHRA as the lead authority and will use its communication channels to promote any information/guidance produced by the MHRA. They will also consider if HSE guidance document INDG459 should be updated to reflect any new information/guidance produced. MHRA has commenced a dialogue with the Association of Anaesthetists and the Safe Anaesthesia Liaison Group of the Royal College of Anaesthetists to raise awareness of ignition within valve components of oxygen cylinders. MHRA was represented on a multiagency group which hopes to publish guidance once ratified by the Councils of both the RCoA and the AA.
Michael Woods
All Responded
2021-0015 18 Jan 2021 County of Dorset
National Rifle Association and National…
Concerns summary (AI summary) Shooting range staff lack consistent national training in identifying abnormal behaviour or conducting emergency response exercises, which could significantly improve safety protocols for participants.
Action Planned (AI summary) The NRA and NSRA will develop training for staff at their ranges on identifying and responding to potential self-harm, to be delivered by September 2021. They will review their emergency response procedures, testing them twice yearly, and will publish guidance for other rifle ranges by October 2021.
Linda Gillchrest
Partially Responded
2021-0002 4 Jan 2021 County of Surrey
Department of Health and Social Care eBay UK Ltd
Concerns summary (AI summary) Unrestricted online access to detailed suicide instructions and the ability to purchase lethal quantities of substances without safeguards pose significant risks to vulnerable individuals.
Action Planned (AI summary) The Department of Health and Social Care highlights ongoing actions to reduce suicide rates through the Suicide Prevention Strategy and Workplan, including reducing access to means online. They are also working with online platforms and chemical sellers to raise awareness of suicide risks and provide support resources.
Ruben Bousquet
All Responded
2020-0298 18 Dec 2020 London Inner South
Department of Health and Social Care Food Standards Agency Ministry of Housing, Communities and Lo…
Concerns summary (AI summary) Weak reporting and information sharing processes for food allergy fatalities hinder timely investigations and learning. The feasibility of food businesses carrying adrenaline auto-injectors also needs official investigation.
Action Planned (AI summary) The MHRA sought advice from the UK Commission on Human Medicines (CHM) on a range of areas to support the effective and safe use of AAIs. The AAI EWG recommended a number of other measures including reinforcement of the need for all patients at risk of anaphylaxis to carry two AAIs at all times. The FSA is undertaking consumer research to gather information and insights from people with food allergies and is considering the benefits of developing a food allergy safety scheme for allergen management within food businesses. They are supporting businesses to prepare for new allergen labelling rules coming into effect on 1st October 2021. The FSA is establishing a way for people to directly report information regarding anaphylactic reactions caused by food allergies that do not result in death. The MHRA is considering making AAI devices more widely available for use in exceptional, emergency situations.
Kevin Branton, Richard Smith, Audrey Cook, Alfred Cook and Maureen Cook
Partially Responded
2020-0274 7 Dec 2020 Cornwall and Isles of Scilly
Department of Business, Energy and Indu… Office for Product Safety and Standards
Concerns summary (AI summary) The absence of a national database for gas appliances hinders rapid identification and tracing of dangerous items. Lack of mandatory recording impedes urgent communication and tracing between stakeholders.
Action Planned (AI summary) The Department for Business, Energy & Industrial Strategy (BEIS) has asked the Office for Product Safety and Standards (OPSS) to engage with manufacturers, retailers, consumer groups, and government bodies to discuss effective communication about potentially dangerous appliances and develop an action plan. OPSS will also assess the gas appliance market, consumer trends, and whether further research is needed to change consumer behaviour towards greater gas safety.
Lee Elliott
All Responded
2020-0265 26 Nov 2020 County of Cumbria
Department of Health and Social Care
Concerns summary (AI summary) Toxic substances are easily and cheaply obtainable online without safeguards, and are advocated on websites as a method for suicide, leading to multiple deaths.
Noted (AI summary) The Department acknowledges concerns about the availability of suicide methods online and outlines actions to reduce suicide rates through the Suicide Prevention Strategy for England, including reducing access to the means of suicide and working with online retailers of harmful substances.
Jean Williams
All Responded
2020-0239 16 Nov 2020 Manchester (West)
NHS England, Blackpool Teaching Hospita…
Concerns summary (AI summary) Bed levers are improperly fitted by untrained staff without patient assessment, and policy gaps hinder reporting concerns. Miscommunication prevents trained professionals from fitting them, and there is a risk of supplying levers without essential safety straps for Divan beds.
Action Taken (AI summary) Blackpool Teaching Hospitals addressed concerns about bed lever fitting at Thornton House by clarifying that Occupational Therapists, now correctly trained, will prescribe and fit them after a full assessment. The intermediate care team and LCC were informed of updated processes at a meeting on December 2, 2020, and the Trust shared findings with senior Allied Health Professionals across the Lancashire and South Cumbria Integrated Care System. Lancashire County Council updated their 'Bed Rail and Bed Lever Policy and Procedure' to clarify the escalation process for concerns, effective January 8, 2021, with a further review planned for April 2021. They also rectified a miscommunication regarding bed lever usage at Thornton House, agreeing with Blackpool Teaching Hospitals that bed levers can be used when appropriate and fitted only by trained Occupational Therapy staff. Mobility 2000 Ltd has carried out further training with staff on fitting bed levers and straps, and will now supply a hard copy of the manufacturer's instructions with every bed lever.
Pauline Oakley
All Responded
2020-0304 18 Sep 2020 Inner North London
East End Homes, East London NHS Foundat…
Concerns summary (AI summary) There was no safety assessment of the patient's flat or appliances upon hospital discharge. Additionally, the fire alarm system was unmonitored, relying on residents who may have assumed it was.
Noted (AI summary) East London NHS Foundation Trust clarifies that responsibility for environmental risk assessments following the patient's discharge from hospital would lie with the Reablement Team, which falls within the remit of the London Borough of Tower Hamlets. However, they will discuss the case within their regular team meetings. East End Homes states that the smoke alarms were of an appropriate standard, properly installed, maintained, and operated when activated. They believe that residents do not expect domestic alarms to be monitored externally, and they offer general guidance on fire safety. The GP practice will ensure the multi-disciplinary team and Social Services are made aware of concerns raised about the adequacy or safety of a patient's home environment. Clinicians can prompt the Care Navigator or Social Worker at the monthly Integrated Care Multidisciplinary Meeting to ensure that appropriate fire safety checks are implemented.
Brenda Elmer
All Responded
2020-0159 14 Aug 2020 West Sussex
NHS England Public Health England
Concerns summary (AI summary) Discharged patients were not effectively informed about a hospital-acquired Listeria outbreak, delaying diagnosis. Additionally, there are no legal requirements for private labs or hospitals to share Listeria isolates, hindering timely outbreak identification.
Action Taken (AI summary) PHE implemented an Incident Management Team following listeria cases, inspected the sandwich manufacturer, and wrote to national microbiological standards to update the SOP for identification of Listeria. The updated SOP advises hospital laboratories to refer all isolates from patients to PHE.
Thiago Araujo
Partially Responded
2021-0132 29 Jan 2020 East London
AMHP London Borough of Camden Camden and Islington NHS Foundation Tru… +4 more
Concerns summary (AI summary) The provided concerns text is incomplete, preventing a proper summary of the identified safety issues.
Noted (AI summary) The Trust has implemented an additional recommendation that discharge of Crisis Team service users due to non-engagement must be discussed in a multidisciplinary meeting with senior overview, and clearly communicated to relevant parties. Legal advice has been sought and guidance circulated to staff regarding potentially dangerous packages. Royal Mail asserts that their processes for handling restricted and prohibited items are adequate and appropriate, given the legal restrictions on interfering with postal packets. They state that they do not intend to take any action in response to the report. The MPS is developing a Suicide Prevention Policy Document and Toolkit. An investigative standards document is also under development as guidance for police first responders. The Department of Health and Social Care describes actions taken to limit the availability of chemicals used in suicides, including working with a chemical supplier to identify suppliers on online retail platforms and noting eBay's global prohibition of the sale of the chemical. It also notes work with the media to improve suicide reporting and the publication of an Online Harms White Paper. The Home Office is aiming to establish a consultation this summer on possible amendments to the Poisons Act, which will include more obligations on online marketplaces including reporting suspicious transactions within 24 hours.
Janet Jasper
All Responded
2020-0014 17 Jan 2020 Rutland and North Leicestershire
Cadent Gas Ltd Gas Safe Network Institution of Gas Engineers +2 more
Concerns summary (AI summary) Hundreds of properties face a risk of floor failure, and there is inconsistency across gas distribution networks regarding protocols for inspecting adjoining properties after an incident.
Action Planned (AI summary) Following a review, Gas Distribution Networks (GDNs) have agreed on a revised EM72 policy for responding to gas leak callouts, particularly "no trace" declarations. HSE also undertook communication with residents and gas engineers in the local area, including hosting a residents meeting and providing leaflets to explain potential risks and actions. Gas Distribution Networks (GDNs) clarified procedures for checking adjoining properties during internal gas escape investigations, focusing on external sources. The GDNs will brief operational teams on the revised requirements, expected to be in place across all networks by mid-summer 2020.