Medical Product Allergen Labelling
Unclear labelling, inconsistent nomenclature, and insufficient research regarding allergens in medical products.
Strongest theme matches
Mixed across source types and ranked by classifier confidence plus text match strength.
PFD report
97match
Andrew Cook
The coroner noted potential under-reporting of PEG allergy and a need for more research into its effects. Concerns were raised about the lack of clear information on medical product labelling regarding PEG's presence, dose, and molecular weight, compounded by inconsistent nomenclature.
Matched on
terms: labelling, medical, product
PFD report
73match
Natasha Ednan-Laperouse
The coroner identified inadequate allergen labelling and a lack of coordinated monitoring for allergic reactions at Pret-a-Manger, alongside concerns about Epipen auto-injectors having insufficient needle length and a lower adrenaline dose than recommended.
Matched on
terms: allergen, labelling
PFD report
65match
John James Jackson
The coroner noted insufficient information regarding the caffeine content and dangers of consuming large quantities of 'Hero Energy Mints.' The product's ambiguous classification between medication and sweets raised concerns about consumers potentially mistaking it for ordinary confectionery.
Matched on
terms: product
PFD report
65match
Christopher Holyoake
The coroner notes a lack of awareness regarding the flammability of paraffin-based E45 cream among carers and the deceased, attributed to insufficient communication from the GP and an absence of fire hazard warnings on the product packaging and prescription.
Matched on
terms: product
PFD report
65match
Dildar Shariff
The coroner notes insufficient awareness among medical professionals and in NICE guidelines regarding the elevated haemorrhage risk for haemodialysis or uremic patients after a head injury. This gap in guidance could pose a risk to future patients.
Matched on
terms: medical
PFD report
65match
Victor Hall
The coroner noted concerns regarding a medication error partly attributed to the Phosphate Polyfusor product design and staff not checking medication packaging against prescriptions. Insufficient guidance, documentation, and training were also identified for healthcare professionals on medication administration and transfer procedures.
Matched on
terms: product
PFD report
65match
Owen Carey
Concerns were raised regarding the adequacy and effectiveness of allergen training for restaurant staff, particularly with high turnover, and the insufficient prominence of allergen notices on menus. Additionally, menus lacked explicit key allergen information, potentially leading to false reassurance for customers.
Matched on
terms: allergen
PFD report
65match
Angela Kearn
The coroner noted limited medical awareness of Immersion Pulmonary Oedema and the absence of specific standards for full face snorkel masks during their development. There were also concerns about insufficient communication of safety warnings to existing mask owners regarding use by individuals with cardio-respiratory conditions.
Matched on
terms: medical
PFD report
61match
Samantha Hopkins
The coroner noted that PARAMEDIC 2 Trial exclusion criteria, including for pregnant women, were overlooked due to insufficient prominence on drug packets. There was also a lack of guidance from Warwick Medical School on how to highlight these exclusions to participants.
Matched on
terms: medical
PFD report
61match
Venkata Kagga
The coroner noted insufficient safety features for button batteries in household devices and a lack of understanding of their risks. Concerns were also raised about non-compliance with policies for young children in emergency services, inadequate medical assessments, and poor information sharing across NHS services.
Matched on
terms: medical
PFD report
61match
Celia Marsh
The coroner identified outdated pathology guidance and inadequate sample retention in suspected anaphylaxis death investigations. Concerns also include gaps in education for doctors and patients regarding severe food allergies and a need for improved food labelling practices.
Matched on
terms: labelling
HSSIB recommendation
60match
The use of an appropriate flush fluid with arterial lines
HSIB recommends that the Medicines and Healthcare products Regulatory Agency engages with other national regulators and relevant stakeholders to develop design guidance on labelling and packaging specific to fluids to reduce selection errors.
Matched on
terms: labelling, product
PFD report
57match
William Andrews
The coroner noted issues with medical equipment design, specifically syringe caps not being brightly coloured or visually distinct, and a lack of awareness among surgical teams that certain syringes now come with caps. Concerns also included the absence of a standard procedure for counting or checking these caps after operations.
Matched on
terms: medical
PFD report
57match
Patricia Mellor
The coroner raises concerns that the Medicines and Healthcare Products Regulatory Agency (MHRA) and NICE have not acted on recommendations to update product information warnings for anaesthetic agents and revise pre-operative assessment guidelines concerning Long QT Syndrome.
Matched on
terms: product
PFD report
57match
Stephen Myers
The coroner identified that the labelling and packaging of isopropyl nitrite, sold as 'English Room Odoriser', were inadequate under current CLP regulations, lacking updated hazard warnings, pictograms, precautionary statements, and a tactile warning.
Matched on
terms: labelling
PFD report
57match
Jonathan Weatherley
Previous product recall notices contained shortcomings, prompting the coroner to identify a need for a new, comprehensive recall. This recall should detail all known problems and affected products, and be widely disseminated collaboratively.
Matched on
terms: product
PFD report
57match
Ronald Clark
Stents of varying sizes are supplied in identical packaging, which increases the risk of the wrong size being used during medical procedures due to difficult identification. The coroner recommends purchasing agencies ensure manufacturers use distinct coloured packaging for different stent sizes.
Matched on
terms: medical
PFD report
53match
Irene Pearson
The coroner raised concerns about the clarity of Matrifen leaflet warnings regarding hot baths and Macmillan Nurses' advice on patch removal. There were also identified gaps in liaison between Macmillan Nurses and the GP practice, alongside unclear GP patient notes.
Matched on
classifier match
PFD report
53match
Rubana Pathan
The coroner noted insufficient dissemination of information to healthcare providers and implant manufacturers regarding how a specific toxin, linked to breast implant sepsis, can suppress signs of local inflammation.
Matched on
classifier match
PFD report
49match
Victoria Meppen-Walter
The coroner raised concerns regarding the availability and regulation of chloroquine, noting the associated risk of misuse.
Matched on
classifier match
PFD report
49match
Tiya Chauhan
The coroner raised concerns that the choking risks associated with raw jelly cubes are not sufficiently appreciated by childcare settings and parents. The report notes a lack of warnings on raw jelly packaging and insufficient supervision when used in play.
Matched on
classifier match
PFD report
49match
Steven Curtis
The coroner raises concerns about the safety of Maplin N19KJ telescopic ladders, noting approximately 43,000 units were sold before withdrawal due to safety issues. Further investigation is sought regarding the accident ladder's origin and a review by Maplin.
Matched on
classifier match
PFD report
49match
Kathryn Bull
The report describes a lack of understanding regarding the rare hyperammonaemia syndrome, an adverse consequence of gastric bypass surgery, and its symptoms.
Matched on
classifier match
PFD report
49match
Pauline Taylor
The coroner raised concerns about the fire hazard of emollient creams with low paraffin content, citing inadequate warnings on packaging and insufficient awareness of these risks. Locala also did not update risk assessments after significant patient changes.
Matched on
classifier match
PFD report
49match
Christina Fletcher
The coroner noted the absence of specific guidance from the GPhC for pharmacies on 'red flag' systems for patients with similar identifying details. Concerns were also raised about the lack of clear guidance on the chain of custody for Controlled Drugs, leading to inconsistent local practices.
Matched on
classifier match
PFD report
49match
Michael Spencer
The coroner raised concerns regarding the non-availability of Andexanet alfa, a reversal agent for Factor Xa inhibitor anticoagulants, in the UK, given the increasing clinical use of these drugs.
Matched on
classifier match
PFD report
49match
Katherine Stamp
The coroner noted that clozapine's side effects, especially relating to smoking and pneumonia, are under-appreciated, and the BNF does not provide sufficient clarity to prescribers regarding these effects.
Matched on
classifier match
PFD report
49match
Maureen Waterfall
The coroner noted the absence of a licensed antidote for Edoxaban and insufficient sharing of associated bleeding risks with non-tertiary centres. Concerns also included a lack of national guidance for antidote administration target times and storage.
Matched on
classifier match
PFD report
49match
Samantha Singh
Concerns were raised regarding the surgery's incorrect categorisation of a RAST test, the prescription of a single EpiPen contrary to NICE guidance, and the lack of a referral to an allergy clinic or follow-up.
Matched on
classifier match
PFD report
49match
Susan Skillen
The coroner noted that patient literature for methotrexate did not include phototoxicity as a rare side effect, and it was unclear whether this literature would be reviewed after a Yellow Card report.
Matched on
classifier match
PHSO casework decision
48match
P-003990 - Medicines and Healthcare products Regulatory Agency (MHRA)
Mrs C complained the Medicines and Healthcare products Regulatory Agency (MHRA) did not follow standards when changing its policy on valproate medicines, risking her life.
Matched on
terms: product
Committee recommendation
47match
#65 - Lack of NHS access to cannabis-based medicinal products for patients.
We support cannabis-based products for medicinal use (CBPMs) where there is an evidence base that it can be an effective form of treatment for managing conditions or symptoms. We welcome the ACMD conducting a further assessment of CBPMs following on from its 2020 report. However, we are concerned that there is currently a lack of access on the...
Matched on
terms: medical, product
PFD report
45match
Leo Deady
The coroner notes a significant rate of undiagnosed breech presentations and the absence of national guidelines for routine late-stage pregnancy scans to detect them, with no national consideration of the risks, benefits, and funding implications.
Matched on
classifier match
PFD report
45match
Jackie Scott
The coroner noted that a take-away meal consumed by Jackie Scott contained peanuts or peanut oil, of which he was unaware, leading to a fatal allergic reaction.
Matched on
classifier match
PFD report
45match
Dafydd Watts
The coroner noted that the possibility of a rare drug occurrence is not highlighted to physicians in drug literature or in the BNF entry.
Matched on
classifier match
PFD report
45match
Archie Hames
Independent expert testing found that the combined use of a specific tracheostomy tube and a particular Velcro strap compromised the tube's integrity, likely causing its detachment. The coroner also raised concerns about the broader implications for continued use of Velcro strap attachments with tracheostomy tubes.
Matched on
classifier match
PFD report
45match
George Stone
National guidelines for warnings given to patients prescribed certain antidepressants do not currently include the risk of severe seizures, a known potential side effect of these medications.
Matched on
classifier match
PFD report
45match
James Fyfe
The coroner identified a design and maintenance issue allowing a trolley's cot side to remain raised but unlocked, with uncertainty about its inclusion in maintenance schedules. It was also noted the MHRA did not escalate this known risk to other hospital trusts.
Matched on
classifier match
PFD report
45match
Annette Charlton
The coroner noted that manufacturers producing medications in almost identical packaging may contribute to dispensing errors and potentially to patient deaths.
Matched on
classifier match
PFD report
45match
Brian Marks
The coroner noted the similar appearance of PEJ and PEG tubes could lead to confusion, suggesting a simple colour coding system to aid differentiation when the tubes are in situ.
Matched on
classifier match
PFD report
45match
Dilys Jenkins
The coroner raises concerns that standard tracheostomy tube lengths may be inappropriate for the increasing size of the population, potentially contributing to complications like dislodgement. The Intensive Care Society is encouraged to influence the industry to address this issue.
Matched on
classifier match
PFD report
45match
Nadine Brookes-Walker
The packaging of Fentanyl patches may not sufficiently warn patients about the serious consequences of using damaged patches.
Matched on
classifier match
PFD report
45match
Patricia Thomas
The coroner noted a potential drug interaction between Miconazole Gel and Warfarin, which can increase bleeding risk. There is a lack of awareness of this interaction among health professionals and difficulty in locating clear information.
Matched on
classifier match
PFD report
45match
Raymond Woodward
The coroner noted that the risk of an adverse reaction to Buscopan in patients with coronary artery disease is not widely known. The current SPC for intravenous Buscopan lacks specific caution for those with ischaemic heart disease, suggesting a need for clearer guidance.
Matched on
classifier match
PFD report
45match
Zane Gbangbola
The coroner notes that safety guidance documents for internal combustion engine equipment, particularly for use in confined areas, are inadequate and potentially misleading. The use of the HSE logo on these documents risks implying official endorsement, which could exacerbate harm.
Matched on
classifier match
PFD report
45match
Grace Roseman
The coroner identified concerns about the number of unmodified Bednest cribs still in circulation, where customers may be unaware of the mandatory safety modification or view it as optional, particularly those being passed on or sold secondhand.
Matched on
classifier match
PFD report
45match
Marjorie Bassendine
The coroner noted concerns about the potential for multiple psychotropic medications to prolong the QT interval, highlighting the importance of pre-treatment and regular ECGs to monitor for long QT syndrome.
Matched on
classifier match
PFD report
45match
Margaret Clark
The coroner raised concerns that Ecolab Ultracover sheaths, used for Transoesophageal Echocardiograms (TOEs), may be linked to multiple fatal oesophageal tears. A review of these sheaths is recommended, considering their replacement with Probetection sheaths across all hospitals and Trusts.
Matched on
classifier match
PFD report
45match
Stephen Whitehead
The coroner identified the absence of a national registry for biliary stents, posing a risk of forgotten stents. Additionally, national guidelines lack an operational definition of 'short-term' use for these stents, creating ambiguity about safe timeframes.
Matched on
classifier match
PFD report
45match
Mary Nelson
The coroner raised concerns about Fluoxetine accumulating to dangerous levels that could trigger cardiac rhythm disturbance, questioning if dosage guidance needs revision or in-life drug level testing. Additionally, the death was not reported via the Yellow Card system.
Matched on
classifier match