ALLEVYN GENTLE BORDER 10X20CM 66800900Recalls & 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
- 4
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 05000223476182), received between Oct 19, 2020 and Apr 11, 2021 — classified as 4 malfunctions.
The most frequently reported specific device problem is “Loss of or Failure to Bond” (3 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 Bond3
- Material Separation2
- Material Disintegration1
Patient problems
- No Clinical Signs, Symptoms or Conditions3
- No Patient Involvement1
Recent adverse event reports
The 4 most recent of 4 reports, in the reporter's own words as published by the FDA.
MalfunctionApr 11, 2021Loss of or Failure to Bond; Loss of or Failure to Bond
IT WAS REPORTED THAT DURING INSPECTION UPON REMOVING THE BACKING ON THIS DRESSING A SIGNIFICANT AMOUNT OF THE ADHESIVE ON THE PAD COMES OFF ONTO THE BACKING. NO PATIENT WAS INVOLVED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 11646758 ↗MalfunctionMar 16, 2021Loss of or Failure to Bond; Material Separation; Loss of or Failure to Bond; Material Separation
IT WAS REPORTED THAT MANY PIECES OF THE ADHESIVE EDGE OF THE ALLEVYN GENTLE BORDER DRESSINGS COME LOOSE IN SEVERAL SIZES. IT STICKS TO THE SINK AND THE FLOOR. THIS HAPPENED SPECIALLY TO THE BOTTOM AND SIDES OF THE PATCHES. IT IS UNKNOWN IF A PATIENT WAS INVOLVED. 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 11490633 ↗MalfunctionMar 16, 2021Loss of or Failure to Bond; Material Separation; Loss of or Failure to Bond; Material Separation
IT WAS REPORTED THAT MANY PIECES OF THE ADHESIVE EDGE OF THE ALLEVYN GENTLE BORDER DRESSINGS COME LOOSE IN SEVERAL SIZES. IT STICKS TO THE SINK AND THE FLOOR. THIS HAPPENED SPECIALLY TO THE BOTTOM AND SIDES OF THE PATCHES. IT IS UNKNOWN IF A PATIENT WAS INVOLVED. 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 11490632 ↗MalfunctionOct 19, 2020Material Disintegration; Material Disintegration
IT WAS REPORTED THAT THE SILICONE OF THE ALLEVYN IS OFFSETTING, THERE WERE SILICONE RESIDUES LEFT IN THE BACKING PAPER. NO PATIENT WAS INVOLVED.
Patient problems: No Patient Involvement
MAUDE report 10702004 ↗
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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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