ALLEVYN Gentle Border Sacrum 66020413Recalls & reported problems
Smith & Nephew Medical Limited · ALLEVYN Gentle Border Sacrum 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
- 2
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 05000223476120), received between Nov 25, 2020 and Nov 25, 2020 — classified as 2 injuries.
The most frequently reported specific device problem is “Material Integrity Problem” (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 Integrity Problem2
Patient problems
- Bacterial Infection2
- Skin Infection2
- Pain1
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
InjuryNov 25, 2020Material Integrity Problem; Material Integrity Problem
IT WAS REPORTED THAT THE ADHESIVE QUALITY IS NOT GOOD. THE DRESSING IS PEELING AT THE TOP AND SIDES. DRESSING WAS PLACED ON COX'S (LOWER BACK), IT WAS CHECKED BY DN WHO CONFIRMED THERE WAS NO CREAMS OR MOISTURIZERS WHICH MAY HAVE CAUSED THIS ADHESIVE TO UNSTICK SO SOON. THE WOUND IS CURRENTLY INFECTED WITH STAPHYLOCOCCUS AFTER A SWAB WAS TAKEN ON 21ST OCTOBER. CUSTOMER STARTED A COURSE OF ANTIBIOTICS ON OCT 28TH.
Patient problems: Bacterial Infection; Pain; Skin Infection
MAUDE report 10905747 ↗InjuryNov 25, 2020Material Integrity Problem; Material Integrity Problem
IT WAS REPORTED THAT THE ADHESIVE QUALITY IS NOT GOOD. THE DRESSING IS PEELING AT THE TOP AND SIDES. DRESSING WAS PLACED ON COX'S (LOWER BACK), IT WAS CHECKED BY DN WHO CONFIRMED THERE WAS NO CREAMS OR MOISTURIZERS WHICH MAY HAVE CAUSED THIS ADHESIVE TO UNSTICK SO SOON. THE WOUND IS CURRENTLY INFECTED WITH STAPHYLOCOCCUS AFTER A SWAB WAS TAKEN ON 21ST OCTOBER. CUSTOMER STARTED A COURSE OF ANTIBIOTICS ON OCT 28TH.
Patient problems: Bacterial Infection; Skin Infection
MAUDE report 10905667 ↗
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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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