ALLEVYN Gentle Border Lite 5.5x12cm 66800836Recalls & reported problems
Smith & Nephew Medical Limited · 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
- 2
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 05000223475529), received between Dec 22, 2020 and May 19, 2021 — classified as 2 injuries.
The most frequently reported specific device problem is “Loss of or Failure to Bond” (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
- Adverse Event Without Identified Device or Use Problem1
- Loss of or Failure to Bond1
Patient problems
- Hypersensitivity/Allergic reaction1
- Itching Sensation1
- No Clinical Signs, Symptoms or Conditions1
- Skin Burning Sensation1
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
InjuryMay 19, 2021Loss of or Failure to Bond; Loss of or Failure to Bond
IT WAS REPORTED THAT, IN SEVERAL TREATMENTS, THE SILICONE OF THE ALLEVYN GENTLE BORDER LITE 5.5X12CM REMAINS STRONGLY ON THE BLISTER PACK, BUT ALSO DURING REMOVAL, THE SILICONE REMAINS ON THE HEALTHY SKIN OR ON THE PATIENT'S WOUND, DUE TO THIS THE USE OF THE DRESSING IS BEING REPLACED FOR A COMPETITOR'S DRESSING (MEPILEX FROM MOLNLYCKE). ACCORDING TO SALES REPRESENTATIVES, THIS WAS NOT A PROBLEM ON ONE BATCH, BUT A GENERALIZED PROBLEM. NO PATIENT INJURY OR OTHER COMPLICATIONS WERE REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 11852363 ↗InjuryDec 22, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT THE ADHESIVE ON THE DRESSING HAS LEFT A RED ITCHY MARK ON PATIENT'S SKIN, WHERE THE ADHESIVE AROUND THE ENTIRE CIRCUMFERENCE OF THE PLASTER HAD MADE CONTACT WITH PATIENT'S SKIN. THE PLASTER WAS APPLIED BY A NURSE. WITHIN AN HOUR OF IT BEING APPLIED TO PATIENT'S SKIN, THERE WAS A BURNING, ITCHING SENSATION AND THE DRESSING WAS REMOVED. PATIENT'S SKIN REMAINS ITCHY AND RED FIVE WEEKS AFTER USING THE PRODUCT, WHICH IS CAUSING DISCOMFORT AND DISTRESS. PATIENT HAS BEEN RECEIVING ONGOING TREATMENT FOR THIS ALLERGIC REACTION.
Patient problems: Hypersensitivity/Allergic reaction; Itching Sensation; Skin Burning Sensation
MAUDE report 11060197 ↗
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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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