ALLEVYN Gentle Border 7in x 7in 66800280Recalls & reported problems
Smith & Nephew Medical Limited · ALLEVYN Gentle Border 7in x 7in Silicone gel adhesive hydrocellular foam dressing · Class 1
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 2
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 05000223463991), received between Mar 16, 2021 and Mar 16, 2021 — classified as 2 malfunctions.
The most frequently reported specific device problem is “Material Separation” (2 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
- Material Separation2
- Loss of or Failure to Bond1
Patient problems
- No Clinical Signs, Symptoms or Conditions2
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
MalfunctionMar 16, 2021Material Separation; 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 11490638 ↗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 11490636 ↗
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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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