ALLEVYN Gentle Border Lite 7.5cm x 7.5cm 66020412Recalls & reported problems
Smith & Nephew Medical Limited · ALLEVYN Gentle Border Lite 7.5cm x 7.5cm Silicone gel adhesive hydrocellular sacrum 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 05000223475468), received between Jun 24, 2021 and Aug 2, 2023 — classified as 2 malfunctions.
The most frequently reported specific device problem is “Ambient Noise 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
- Ambient Noise Problem1
- Delivered as Unsterile Product1
- Material Discolored1
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.
MalfunctionAug 2, 2023Delivered as Unsterile Product; Delivered as Unsterile Product
IT WAS REPORTED THAT BEFORE USE, THE ALLEVYN GENTLE BORDER LITE 7.5X7.5CM WAS NOTICED TO BE TRAPPED IN THE SEALING PART OF THE POUCH AND CUT THEREFORE, THE DRESSING WAS NOT INTACT AND THE STERILITY OF THE DRESSING WAS COMPROMISED. THERE WAS NO DELAY AND THE TREATMENT WAS FINISHED USING A SMITH & NEPHEW BACK UP. PATIENT WAS NOT HARMED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17447376 ↗MalfunctionJun 24, 2021Material Discolored; Ambient Noise Problem; Material Discolored; Ambient Noise Problem
IT WAS REPORTED THAT, DURING AN ADVANCE WOUND MANAGEMENT TREATMENT AN ALLEVYN GENTLE BORDER 7.5 CM X 7.5 CM WAS FOUND TO BE STAINED BLUE AND HAD BROWN FOREIGN MATTER ON IT. TREATMENT WAS PERFORMED, WITHOUT ANY DELAY, WITH A BACK-UP DEVICE INSTEAD. PATIENT WAS NOT INJURED AS CONSEQUENCE OF THIS PROBLEM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12057895 ↗
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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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