ALLEVYN Gentle Border Heel 66020407Recalls & reported problems
Smith & Nephew Medical Limited · ALLEVYN Gentle Border Heel Silicone gel adhesive hydrocellular foam heel dressing · Class 1
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 05000223465230), received between Sep 28, 2020 and Sep 28, 2020 — classified as 1 malfunction.
The most frequently reported specific device problem is “Product Quality Problem” (1 report).
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
- Product Quality Problem1
Patient problems
- No Consequences Or Impact To Patient1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
MalfunctionSep 28, 2020Product Quality Problem; Product Quality Problem
IT WAS REPORTED THAT ALLEVYN GENTLE BORDER HEEL 23 CM X 23.2 CM 5 PACK RECENTLY ONE OF THE HEALTHCARE PROFESSIONALS AT (B)(6) HAD ASKED FOR SAMPLES FOR ALTERNATIVE TO THE ALLEVYN LIFE HEEL. THE HEALTHCARE PROFESSIONAL THEN HAD A FELLOW COWORKER "WHERE" THE HEEL JUST TO TEST OUT BEFORE USING IT ON A PATIENT. ALTHOUGH THE HEEL DRESSING DID FIT BETTER AND WAS MUCH MORE COMFORTABLE IT DID LEAVE BEHIND GEL BEADS AS WELL AS A STICKY SILICON ON THE COWORKERS FOOT.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 10593608 ↗
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- 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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