ALLEVYN LIFE HEEL 66021304Recalls & reported problems
Smith & Nephew Medical Limited · Soft Silicone Hydrocellular Heel Dressing with Lock Away Layer · Class 1
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 9
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 9 adverse event reports that list this exact device (DI 05000223482503), received between Dec 3, 2020 and Oct 10, 2025 — classified as 9 malfunctions.
The most frequently reported specific device problem is “Delivered as Unsterile Product” (4 reports).
Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.
Reports received per month
Most reported problems
Device problems
- Delivered as Unsterile Product4
- Nonstandard Device2
- Device Damaged Prior to Use1
- Loss of or Failure to Bond1
- Material Integrity Problem1
Patient problems
- No Clinical Signs, Symptoms or Conditions9
Recent adverse event reports
The 9 most recent of 9 reports, in the reporter's own words as published by the FDA.
MalfunctionOct 10, 2025Delivered as Unsterile Product; Delivered as Unsterile Product
IT WAS REPORTED THAT THE ALLEVYN LIFE HEEL (GLOBAL) PACK OF 5 PACKAGING WAS NOT INTACT AND WAS FOUND IN A TORN CONDITION. AS THIS WAS NOTICED IN A NON-THERAPEUTIC ENVIRONMENT, THERE WAS NOT PATIENT INVOLVED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23265826 ↗MalfunctionFeb 9, 2022Delivered as Unsterile Product; Delivered as Unsterile Product
IT WAS REPORTED THAT THE ALLEVYN LIFE HEEL DRESSINGS FROM LOT NUMBER 202127 SHOWS A BUBBLE IN THE PACKAGING, SO STERILITY IS NO LONGER ASSURED. AS THIS WAS NOTICED UPON INSPECTION, THE PATIENT WAS NOT INVOLVED AT THAT MOMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 13502220 ↗MalfunctionFeb 9, 2022Delivered as Unsterile Product; Delivered as Unsterile Product
IT WAS REPORTED THAT THE ALLEVYN LIFE HEEL DRESSINGS FROM LOT NUMBER 202123 SHOWS A BUBBLE IN THE PACKAGING, SO STERILITY IS NO LONGER ASSURED. AS THIS WAS NOTICED UPON INSPECTION, THE PATIENT WAS NOT INVOLVED AT THAT MOMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 13502199 ↗MalfunctionNov 30, 2021Delivered as Unsterile Product; Delivered as Unsterile Product
IT WAS REPORTED THAT THE POUCH OF A ALLEVYN LIFE HEEL 25CM X 25.2CM PACK WAS NOT SECURELY SEALED BECAUSE A CUT-OFF PIECE OF EXTRA DRESSING HAS BEEN TRAPPED IN THE SEALING PART. AS THIS WAS NOTICED AT THE SALES OFFICE, THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12899750 ↗MalfunctionMar 7, 2021Nonstandard Device; Nonstandard Device
IT WAS REPORTED THAT, DURING DRESSING CHANGE, SILICONE IS COMING AWAY FROM THE DRESSING ONTO THE LINER WHILE REMOVING THE LINER FOR APPLICATION AND ALSO SILICONE IS STAYING ON THE SKIN/WOUND WHILE REMOVING THE DRESSING TO REPLACE WITH A NEW DRESSING. IT IS UNKNOWN WHEN DID THE EVENT HAPPENED HOW WAS THE PROCEDURE FINISHED AND IF THERE WAS A DELAY. NO OTHER COMPLICATIONS WHERE REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 11429788 ↗MalfunctionMar 7, 2021Nonstandard Device; Nonstandard Device
IT WAS REPORTED THAT, DURING DRESSING CHANGE, SILICONE IS COMING AWAY FROM THE DRESSING ONTO THE LINER WHILE REMOVING THE LINER FOR APPLICATION AND ALSO SILICONE IS STAYING ON THE SKIN/WOUND WHILE REMOVING THE DRESSING TO REPLACE WITH A NEW DRESSING. IT IS UNKNOWN WHEN DID THE EVENT HAPPENED HOW WAS THE PROCEDURE FINISHED AND IF THERE WAS A DELAY. NO OTHER COMPLICATIONS WHERE REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 11429787 ↗MalfunctionFeb 3, 2021Device Damaged Prior to Use; Device Damaged Prior to Use
IT WAS REPORTED THAT AFTER A FEW HOURS SINCE THE APPLICATION OF THE DRESSINGS, IT DIDN¿T ADHERE TO THE HEELS. IT SEEMS THAT THE DRESSING DIDN¿T STAY IN A PLACE LIKE IT SHOULD STAY AND SEEMS LOOSE. THE PRODUCT DIDN¿T MATCH ITS PROPERTIES. THERE WERE NO DELAYS AND THE TREATMENT WAS COMPLETED WITH A BACKUP DEVICE. THERE WAS NO PATIENT HARM REPORTED. RESULTS OF THE INVESTIGATION HAVE CONCLUDED THAT THIS DEVICE PRESENTED SILICONE REMAINED ON THE CARRIER, WHICH MAKES IT A REPORTABLE EVENT. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED. IF ADDITIONAL INFORMATION SHOULD BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED ACCORDINGLY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 11273886 ↗MalfunctionDec 10, 2020Loss of or Failure to Bond; Loss of or Failure to Bond
IT WAS REPORTED THAT THE SILICON ADHESION IS COMING OFF ONTO THE PLASTIC BACKING. THE PRODUCT HAS NOT BEEN SUBMITTED TO A CUSTOMER OR USED ON A PATIENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 10987541 ↗MalfunctionDec 3, 2020Material Integrity Problem; Material Integrity Problem
IT WAS REPORTED THAT THE SILICON ADHESION IS COMING OFF ONTO THE PLASTIC BACKING. THE PRODUCT HAS NOT BEEN SUBMITTED TO A CUSTOMER OR USED ON A PATIENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 10939319 ↗
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- DUODERM 187662Convatec, Purchasing Department · Dressing, Wound, Occlusive43 reports
- ALLEVYN LIFE L 15.4X15.4 CTN10 66801069Smith & Nephew Medical Limited · Dressing, Wound, Occlusive28 reports
Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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