ALLEVYN GB MULTISITE CTN 10 66800959Recalls & 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
- 7
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 05000223476502), received between Sep 9, 2020 and May 19, 2021 — classified as 7 malfunctions.
The most frequently reported specific device problem is “Loss of or Failure to Bond” (7 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
- Loss of or Failure to Bond7
Patient problems
- No Clinical Signs, Symptoms or Conditions4
- No Patient Involvement4
Recent adverse event reports
The 7 most recent of 7 reports, in the reporter's own words as published by the FDA.
MalfunctionMay 19, 2021Loss of or Failure to Bond; Loss of or Failure to Bond
IT WAS REPORTED THAT DURING TREATMENT, THE ALLEVYN GB MULTISITE SILICONE STRONGLY REMAINED ON THE PACK WHEN REMOVING IT FOR APPLICATION. ALSO, ONCE THE DRESSING WAS BEING REMOVED FROM THE PATIENT AFTER IT USE, THE SILICONE REMAINED ON THE HEALTHY SKIN OR ON THE PATIENT'S WOUND. THIS HAS HAPPENED IN MULTIPLE OCCASIONS, AND THE USE OF THE DRESSING IS BEING REPLACED FOR A COMPETITOR'S DRESSING: MEPILEX FROM MOLNLYCKE. NO PATIENT INJURY OR OTHER COMPLICATIONS WERE REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 11852471 ↗MalfunctionDec 11, 2020Loss of or Failure to Bond; Loss of or Failure to Bond
IT WAS REPORTED THAT, DURING INSPECTION THE ALLEVYN GB MULTISITE CTN 10 SILICONE WAS OFFSETTING TO THE BACK COVER LEAVING THE FOAM PAD WITHOUT SILICONE IN VARIOUS AREAS. IT WAS A DELAY GREATER THAN 30 MIN. THE PATIENT WAS NOT INJURED AND THE PROCEDURE WAS COMPLETED WITH A SMITH-NEPHEW BACK UP DEVICE. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED. IF ADDITIONAL INFORMATION SHOULD BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED ACCORDINGLY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 10991413 ↗MalfunctionDec 11, 2020Loss of or Failure to Bond; Loss of or Failure to Bond
IT WAS REPORTED THAT, DURING INSPECTION THE ALLEVYN GB MULTISITE CTN 10 SILICONE WAS OFFSETTING TO THE BACK COVER LEAVING THE FOAM PAD WITHOUT SILICONE IN VARIOUS AREAS. IT WAS A DELAY GREATER THAN 30 MIN. THE PATIENT WAS NOT INJURED AND THE PROCEDURE WAS COMPLETED WITH A SMITH-NEPHEW BACK UP DEVICE. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED. IF ADDITIONAL INFORMATION SHOULD BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED ACCORDINGLY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 10991384 ↗MalfunctionSep 9, 2020Loss of or Failure to Bond; Loss of or Failure to Bond
IT WAS REPORTED THAT THE KNOWN ISSUE WITH SILICONE OCCURRED. OLD PRODUCTION WAS DELIVERED TO CUSTOMER AGAINST EARLIER AGREED INTERVENTION. NO PATIENT WAS INVOLVED.
Patient problems: No Patient Involvement
MAUDE report 10511306 ↗MalfunctionSep 9, 2020Loss of or Failure to Bond; Loss of or Failure to Bond
IT WAS REPORTED THAT THE KNOWN ISSUE WITH SILICONE OCCURRED. OLD PRODUCTION WAS DELIVERED TO CUSTOMER AGAINST EARLIER AGREED INTERVENTION. NO PATIENT WAS INVOLVED.
Patient problems: No Patient Involvement
MAUDE report 10509953 ↗MalfunctionSep 9, 2020Loss of or Failure to Bond; Loss of or Failure to Bond
IT WAS REPORTED THAT THE KNOWN ISSUE WITH SILICONE OCCURRED. OLD PRODUCTION WAS DELIVERED TO CUSTOMER AGAINST EARLIER AGREED INTERVENTION. NO PATIENT WAS INVOLVED.
Patient problems: No Clinical Signs, Symptoms or Conditions; No Patient Involvement
MAUDE report 10508702 ↗MalfunctionSep 9, 2020Loss of or Failure to Bond; Loss of or Failure to Bond
IT WAS REPORTED THAT THE KNOWN ISSUE WITH SILICONE OCCURRED. OLD PRODUCTION WAS DELIVERED TO CUSTOMER AGAINST EARLIER AGREED INTERVENTION. NO PATIENT WAS INVOLVED.
Patient problems: No Patient Involvement
MAUDE report 10508678 ↗
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- 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
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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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