ALLEVYN LIFE S 10.3X10.3 CTN10 66801067Recalls & reported problems
Smith & Nephew Medical Limited · Soft Silicone Hydrocellular Foam Dressing with Lock Away Layer · Class 1
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 14
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 14 adverse event reports that list this exact device (DI 05000223477981), received between Dec 4, 2020 and Oct 25, 2022 — classified as 1 injury, 13 malfunctions.
The most frequently reported specific device problem is “Loss of or Failure to Bond” (10 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.
Most reported problems
Device problems
- Loss of or Failure to Bond10
- Contamination3
- Unexpected Color3
- Difficult to Remove1
Patient problems
- No Clinical Signs, Symptoms or Conditions13
- Discomfort1
- Wound Dehiscence1
Recent adverse event reports
The 14 most recent of 14 reports, in the reporter's own words as published by the FDA.
InjuryOct 25, 2022Difficult to Remove; Difficult to Remove
IT WAS REPORTED THAT, DURING TREATMENT WITH A FOAM DRESSING ALLEVYN LIFE 4 X 4" QUADRILOBE STERILE, AFTER 8 HOURS, WHEN THE PATIENT TRIED TO GET THE DRESSING OFF, THE ADHESIVE STUCK TO THE WOUND, AND PULLED OFF THE VERY SCABS THAT WERE DESPERATELY TRYING TO HEAL, IT RESULTED THE RE-OPENING OF THE WOUND. IT IS UNKNOWN HOW THE TREATMENT WAS COMPLETED.
Patient problems: Discomfort; Wound Dehiscence
MAUDE report 15666400 ↗MalfunctionAug 17, 2021Contamination; Unexpected Color; Contamination; Unexpected Color
IT WAS REPORTED THAT AN ALLEVYN LIFE S 10.3X10.3 CTN10 WAS FOUND TO HAVE BROWN COLOR/DARK SPOTS ON IT. NO PATIENT INVOLVED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12332549 ↗MalfunctionAug 17, 2021Contamination; Unexpected Color; Contamination; Unexpected Color
IT WAS REPORTED THAT AN ALLEVYN LIFE S 10.3X10.3 CTN10 WAS FOUND TO HAVE BROWN COLOR/DARK SPOTS ON IT. NO PATIENT INVOLVED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12332525 ↗MalfunctionAug 17, 2021Contamination; Unexpected Color; Contamination; Unexpected Color
IT WAS REPORTED THAT AN ALLEVYN LIFE S 10.3X10.3 CTN10 WAS FOUND TO HAVE BROWN COLOR/DARK SPOTS ON IT. NO PATIENT INVOLVED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12332505 ↗MalfunctionDec 5, 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 10950231 ↗MalfunctionDec 4, 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 10950199 ↗MalfunctionDec 4, 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 10950181 ↗MalfunctionDec 4, 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 10950118 ↗MalfunctionDec 4, 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 10949580 ↗MalfunctionDec 4, 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 10949546 ↗MalfunctionDec 4, 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 10949538 ↗MalfunctionDec 4, 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 10949535 ↗MalfunctionDec 4, 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 10949529 ↗MalfunctionDec 4, 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 10949455 ↗
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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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