Allevyn Gentle Border 10 x 10cm Ctn 10 66800270Recalls & reported problems
Smith & Nephew Medical Limited · Silicone gel adhesive hydrocellular foam dressing · Class 1
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 11
- Deaths reported
- 0
- Injuries reported
- 5
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 11 adverse event reports that list this exact device (DI 05000223463908), received between Jul 24, 2020 and Mar 22, 2021 — classified as 5 injuries, 6 malfunctions.
The most frequently reported specific device problem is “Loss of or Failure to Bond” (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.
Most reported problems
Device problems
- Loss of or Failure to Bond4
- Adverse Event Without Identified Device or Use Problem3
- Detachment of Device or Device Component2
- Material Integrity Problem2
- Separation Problem2
Patient problems
- No Clinical Signs, Symptoms or Conditions4
- Rash3
- Foreign Body In Patient2
- Injury2
- No Patient Involvement2
- No Consequences Or Impact To Patient1
Recent adverse event reports
The 11 most recent of 11 reports, in the reporter's own words as published by the FDA.
MalfunctionMar 22, 2021Loss of or Failure to Bond; Loss of or Failure to Bond
IT WAS REPORTED THAT, THERE WAS SILICONE COMING OFF AN ALLEVYN GENTLE BORDER POTENTIALLY THEREFORE BEING IN THE WOUND. IT IS UNKNOWN WHEN DID THE EVENT HAPPENED, WHAT PROCEDURE WAS BEING PERFORMED, HOW WAS THE PROCEDURE FINISHED AND IF THERE WAS A DELAY. NO OTHER COMPLICATIONS WERE REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 11546514 ↗MalfunctionJan 19, 2021Loss of or Failure to Bond; Loss of or Failure to Bond
IT WAS REPORTED THAT A SILICONE LAYER PROBLEM OCCURRED TO THE ALLEVYN GENTLE BORDER DRESSING. DURING SET-UP PARTICLES OF SILICONE CAME LOOSE OF THE SILICONE LAYER. PATIENT RECEIVED A NEW BOX. NO DELAY NOR PATIENT HARM REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 11197558 ↗InjuryJan 13, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT 3 X PATIENTS HAVE HAD A REACTION TO THE ALLEVYN GENTLE BORDER ADHESIVE AND DEVELOPED A RASH UNDER THE SILICONE. THE RASH WAS WIDESPREAD AND ALL OVER WHERE THE ADHESIVENESS IS. NO OTHER SYMPTOMS. THE ALLEVYN GENTLE BORDER WAS REMOVED AND A NEW ALTERNATE DRESSING APPLIED WITH THE REACTION RESOLVED.
Patient problems: Rash
MAUDE report 11158753 ↗InjuryJan 13, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT 3 X PATIENTS HAVE HAD A REACTION TO THE ALLEVYN GENTLE BORDER ADHESIVE AND DEVELOPED A RASH UNDER THE SILICONE. THE RASH WAS WIDESPREAD AND ALL OVER WHERE THE ADHESIVENESS IS. NO OTHER SYMPTOMS. THE ALLEVYN GENTLE BORDER WAS REMOVED AND A NEW ALTERNATE DRESSING APPLIED WITH THE REACTION RESOLVED.
Patient problems: Rash
MAUDE report 11158676 ↗InjuryJan 13, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT 3 X PATIENTS HAVE HAD A REACTION TO THE ALLEVYN GENTLE BORDER ADHESIVE AND DEVELOPED A RASH UNDER THE SILICONE. THE RASH WAS WIDESPREAD AND ALL OVER WHERE THE ADHESIVENESS IS. NO OTHER SYMPTOMS. THE ALLEVYN GENTLE BORDER WAS REMOVED AND A NEW ALTERNATE DRESSING APPLIED WITH THE REACTION RESOLVED.
Patient problems: Rash
MAUDE report 11158532 ↗MalfunctionDec 28, 2020Loss of or Failure to Bond; Loss of or Failure to Bond
IT WAS REPORTED THAT, THAT THE ALLEVYN LIFE 6X6 BANDAGES ARE NOT LAYING FLAT AND THE ADHESIVE IS NOT ADHERING TO THE SKIN. NO ADDITIONAL INFORMATION WAS PROVIDED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 11081436 ↗MalfunctionNov 11, 2020Loss of or Failure to Bond; Loss of or Failure to Bond
IT WAS REPORTED THAT DURING USE, OUTSIDE THE PATIENT, THE ADHESIVE QUALITIES OF DRESSING NOT LASTING FOR LONGER THAN 12 HOURS. NO SURGICAL DELAY. IT IS UNKNOWN HOW THE PROCEDURE FINISHED. PATIENT INJURIES WERE NOT REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions; No Consequences Or Impact To Patient
MAUDE report 10821840 ↗MalfunctionNov 4, 2020Detachment of Device or Device Component; Detachment of Device or Device Component
IT WAS REPORTED THAT THE SILICONE OF THE ALLEVYN GENTLE BORDER IS OFFSETTING INTO THE BACK COVER LEAVING THE FOAM PAD WITHOUT SILICONE IN VARIOUS AREAS. NO CASE WAS INVOLVED.
Patient problems: No Patient Involvement
MAUDE report 10788546 ↗MalfunctionNov 4, 2020Detachment of Device or Device Component; Detachment of Device or Device Component
IT WAS REPORTED THAT THE SILICONE OF THE ALLEVYN GENTLE BORDER IS OFFSETTING INTO THE BACK COVER LEAVING THE FOAM PAD WITHOUT SILICONE IN VARIOUS AREAS. NO CASE WAS INVOLVED.
Patient problems: No Patient Involvement
MAUDE report 10788541 ↗InjuryJul 24, 2020Material Integrity Problem; Separation Problem; Material Integrity Problem; Separation Problem
IT WAS REPORTED THAT DURING TREATMENT ON REMOVAL OF THE PLASTIC COVER OF THE DRESSING, PART OF THE SILICONE CAME AWAY FROM THE FOAM AND WAS STILL ON THE PLASTIC COVER. ALSO, ON REMOVAL OF THE SAME TYPE OF DRESSING FROM THE PATIENTS SKIN, BITS OF SILICONE WERE STILL ON THE SKIN AND HAD TO BE PICKED OFF. AN INJURY WAS REPORTED
Patient problems: Foreign Body In Patient; Injury
MAUDE report 10323848 ↗InjuryJul 24, 2020Material Integrity Problem; Separation Problem; Material Integrity Problem; Separation Problem
IT WAS REPORTED THAT DURING TREATMENT ON REMOVAL OF THE PLASTIC COVER OF THE DRESSING, PART OF THE SILICONE CAME AWAY FROM THE FOAM AND WAS STILL ON THE PLASTIC COVER. ALSO, ON REMOVAL OF THE SAME TYPE OF DRESSING FROM THE PATIENTS SKIN, BITS OF SILICONE WERE STILL ON THE SKIN AND HAD TO BE PICKED OFF. AN INJURY WAS REPORTED
Patient problems: Foreign Body In Patient; Injury
MAUDE report 10323845 ↗
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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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