ALLEVYN GENTLE BORDER 10X25CM 66800264Recalls & 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
- 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 05000223491833), received between Sep 21, 2020 and Jun 19, 2022 — classified as 1 injury, 13 malfunctions.
The most frequently reported specific device problem is “Nonstandard Device” (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
- Nonstandard Device10
- Loss of or Failure to Bond8
- Delivered as Unsterile Product1
Patient problems
- No Clinical Signs, Symptoms or Conditions11
- No Consequences Or Impact To Patient3
Recent adverse event reports
The 14 most recent of 14 reports, in the reporter's own words as published by the FDA.
MalfunctionJun 19, 2022Delivered as Unsterile Product; Delivered as Unsterile Product
IT WAS REPORTED THAT A ALLEVYN GENTLE BORDER 10X25CM WAS PARTIALLY UNDER THE SEAM AND CONTAINED A SMALL PIECE OF THE SECOND WOUND DRESSING. THE WOUND DRESSING WAS THEREFORE NOT STERILE SINCE IT WAS NOTICED DURING AN INSPECTION, NO PATIENT WAS INVOLVED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 14741296 ↗MalfunctionApr 11, 2021Nonstandard Device; Nonstandard Device
IT WAS REPORTED THAT, WHILE CHECKING THE ALLEVYN DEVICES AND UPON REMOVING THE BACKING ON THIS DRESSING ALMOST ALL OF THE ADHESIVE ON THE PAD COMES OFF ON THE BACKING. NO CASE INVOLVED; THEREFORE, NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 11646756 ↗MalfunctionApr 11, 2021Loss of or Failure to Bond; Nonstandard Device; Loss of or Failure to Bond; Nonstandard Device
IT WAS REPORTED THAT, WHILE CHECKING THE ALLEVYN DEVICES AND UPON REMOVING THE BACKING ON THIS DRESSING ALMOST ALL OF THE ADHESIVE ON THE PAD COMES OFF ON THE BACKING. NO CASE INVOLVED; THEREFORE, NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 11646755 ↗MalfunctionApr 11, 2021Nonstandard Device; Nonstandard Device
IT WAS REPORTED THAT, WHILE CHECKING THE ALLEVYN DEVICES AND UPON REMOVING THE BACKING ON THIS DRESSING ALMOST ALL OF THE ADHESIVE ON THE PAD COMES OFF ON THE BACKING. NO CASE INVOLVED; THEREFORE, NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 11646754 ↗MalfunctionApr 11, 2021Loss of or Failure to Bond; Nonstandard Device; Loss of or Failure to Bond; Nonstandard Device
IT WAS REPORTED THAT, WHILE CHECKING THE ALLEVYN DEVICES AND UPON REMOVING THE BACKING ON THIS DRESSING ALMOST ALL OF THE ADHESIVE ON THE PAD COMES OFF ON THE BACKING. NO CASE INVOLVED; THEREFORE, NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 11646753 ↗MalfunctionApr 11, 2021Loss of or Failure to Bond; Nonstandard Device; Loss of or Failure to Bond; Nonstandard Device
IT WAS REPORTED THAT, WHILE CHECKING THE ALLEVYN DEVICES AND UPON REMOVING THE BACKING ON THIS DRESSING ALMOST ALL OF THE ADHESIVE ON THE PAD COMES OFF ON THE BACKING. NO CASE INVOLVED; THEREFORE, NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 11646752 ↗MalfunctionApr 11, 2021Loss of or Failure to Bond; Nonstandard Device; Loss of or Failure to Bond; Nonstandard Device
IT WAS REPORTED THAT, WHILE CHECKING THE ALLEVYN DEVICES AND UPON REMOVING THE BACKING ON THIS DRESSING ALMOST ALL OF THE ADHESIVE ON THE PAD COMES OFF ON THE BACKING. NO CASE INVOLVED; THEREFORE, NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 11646751 ↗InjuryApr 11, 2021Nonstandard Device; Nonstandard Device
IT WAS REPORTED THAT, WHILE CHECKING THE ALLEVYN DEVICES AND UPON REMOVING THE BACKING ON THIS DRESSING ALMOST ALL OF THE ADHESIVE ON THE PAD COMES OFF ON THE BACKING. NO CASE INVOLVED; THEREFORE, NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 11646750 ↗MalfunctionApr 11, 2021Nonstandard Device; Nonstandard Device
IT WAS REPORTED THAT, WHILE CHECKING THE ALLEVYN DEVICES AND UPON REMOVING THE BACKING ON THIS DRESSING ALMOST ALL OF THE ADHESIVE ON THE PAD COMES OFF ON THE BACKING. NO CASE INVOLVED; THEREFORE, NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 11646749 ↗MalfunctionApr 11, 2021Nonstandard Device; Nonstandard Device
IT WAS REPORTED THAT, WHILE CHECKING THE ALLEVYN DEVICES AND UPON REMOVING THE BACKING ON THIS DRESSING ALMOST ALL OF THE ADHESIVE ON THE PAD COMES OFF ON THE BACKING. NO CASE INVOLVED; THEREFORE, NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 11646748 ↗MalfunctionApr 11, 2021Loss of or Failure to Bond; Nonstandard Device; Loss of or Failure to Bond; Nonstandard Device
IT WAS REPORTED THAT, WHILE CHECKING THE ALLEVYN DEVICES AND UPON REMOVING THE BACKING ON THIS DRESSING ALMOST ALL OF THE ADHESIVE ON THE PAD COMES OFF ON THE BACKING. NO CASE INVOLVED; THEREFORE, NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 11646747 ↗MalfunctionSep 21, 2020Loss of or Failure to Bond; Loss of or Failure to Bond
IT WAS REPORTED THAT THE NURSE IN THE POST OPERATIVE WARD COMPLAINED THAT ALLEVYN GETS LIFTED UP ON THE SAME DAY OF DRESSING DUE TO THEIR POST OPERATIVE DRESSING CARE IS CHALLENGED. THEY HAVE USED COMPETITOR¿S PRODUCT TO SOLVE THIS EVENT.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 10564487 ↗MalfunctionSep 21, 2020Loss of or Failure to Bond; Loss of or Failure to Bond
IT WAS REPORTED THAT THE NURSE IN THE POST OPERATIVE WARD COMPLAINED THAT ALLEVYN GETS LIFTED UP ON THE SAME DAY OF DRESSING DUE TO THEIR POST OPERATIVE DRESSING CARE IS CHALLENGED. THEY HAVE USED COMPETITOR¿S PRODUCT TO SOLVE THIS EVENT.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 10564447 ↗MalfunctionSep 21, 2020Loss of or Failure to Bond; Loss of or Failure to Bond
IT WAS REPORTED THAT THE NURSE IN THE POST OPERATIVE WARD COMPLAINED THAT ALLEVYN GETS LIFTED UP ON THE SAME DAY OF DRESSING DUE TO THEIR POST OPERATIVE DRESSING CARE IS CHALLENGED. THEY HAVE USED COMPETITOR¿S PRODUCT TO SOLVE THIS EVENT.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 10564399 ↗
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- DUODERM 187961Convatec, Purchasing Department · Dressing, Wound, Occlusive153 reports
- SAM Chest Seal CS203-ENSAM Medical Products · Dressing, Wound, Occlusive1 recall0 reports
- FORWARD Gunshot Wound Kit ATF-GSWIntegrated Medcraft LLC · Dressing, Wound, Occlusive1 recall0 reports
- 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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