ALLEVYN Gentle Border Lite 10cm x 10cm 66020408Recalls & reported problems
Smith & Nephew Medical Limited · ALLEVYN Gentle Border Lite 10cm x 10cm Silicone gel adhesive hydrocellular foam 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 05000223475499), received between Mar 24, 2022 and Mar 24, 2022 — classified as 1 malfunction.
The most frequently reported specific device problem is “Delivered as Unsterile Product” (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
- Delivered as Unsterile Product1
Patient problems
- No Clinical Signs, Symptoms or Conditions1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
MalfunctionMar 24, 2022Delivered as Unsterile Product; Delivered as Unsterile Product
IT WAS REPORTED THAT, DURING TREATMENT, WHEN A STERILE POUCH OF AN ALLEVYN GENTLE BORDER LITE 10X10CM WAS TAKEN OUT, IT WAS NOTICED THAT THERE WAS AN 8 CM SIZE UNSEALED PART ON ONE SIDE EDGE. TREATMENT WAS COMPLETED WITH A SN BACK-UP DRESSING. NO HARM TO THE PATIENT OR FURTHER COMPLICATIONS REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 13896538 ↗
Other Dressing, Wound, Occlusive devices
- DUODERM 187957Convatec, Purchasing Department · Dressing, Wound, Occlusive4,342 reports
- DUODERM 187955Convatec, Purchasing Department · Dressing, Wound, Occlusive1 recall2,348 reports
- DUODERM 187660Convatec, Purchasing Department · Dressing, Wound, Occlusive207 reports
- DUODERM 187961Convatec, Purchasing Department · Dressing, Wound, Occlusive153 reports
- SAM Chest Seal CS203-ENSAM Medical Products · Dressing, Wound, Occlusive1 recall0 reports
- 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.
How reports and recalls are matched · Editorial policy · Report an error on this page