Allevyn Gentle Border 7.5x7.5cm Int 66800269Recalls & reported problems

Summary

The FDA's MAUDE database contains 8 adverse event reports that list this exact device (DI 05000223463878), received between Jun 18, 2020 and May 5, 2022 — classified as 4 injuries, 4 malfunctions.

The most frequently reported specific device problem is “Delivered as Unsterile Product” (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

Recent adverse event reports

The 8 most recent of 8 reports, in the reporter's own words as published by the FDA.

• MalfunctionMay 5, 2022Delivered as Unsterile Product; Delivered as Unsterile Product

  IT WAS REPORTED THAT, THE SINGLE PIECE OF THE ALLEVYN GENTLE BORDER 7.5X7.5CM INT IS UNSEALED. IT IS UNKNOWN WHEN THE EVENT HAPPENED OR IF A DELAY OCCUR AND IF A SMITH AND NEPHEW BACKUP DEVICE WAS AVAILABLE TO PERFORM THE INTENDED PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14291283 ↗
• MalfunctionFeb 16, 2022Delivered as Unsterile Product; Delivered as Unsterile Product

  IT WAS REPORTED THAT AN OPENING WAS OBSERVED ON THE PACKAGING OF ONE (1) ALLEVYN GENTLE BORDER 7.5CM X 7.5CM DRESSING. AS THIS WAS NOTICED IN A NON-THERAPEUTICAL ENVIRONMENT, THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13542956 ↗
• MalfunctionSep 1, 2021Device Contaminated During Manufacture or Shipping; Device Contaminated During Manufacture or Shipping

  IT WAS REPORTED THAT, DURING TREATMENT, A ALLEVYN GENTLE BORDER 7.5X7.5CM INT HAD AN INSECT BETWEEN THE FOAM LAYER AND THE TOP FILM. THIS HAPPENED BEFORE USE IN PATIENT. 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 12410387 ↗
• InjurySep 29, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT ONE PATIENT IN A SHORT TIME WHO HAD ALLEVYN GENTLE BORDER DRESSING REACTED TO THE DRESSING. THIS PATIENT HAD AN ITCH IN THE AREA ALONGSIDE THE BORDER OF ALLEVYN GENTLE. THEY USED CORTISONE AND REPLACED WITH MEPILEX BORDER DRESSING.

  Patient problems: Hypersensitivity/Allergic reaction; Itching Sensation; Skin Irritation

  MAUDE report 10603559 ↗
• InjurySep 29, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT ONE PATIENT IN A SHORT TIME WHO HAD ALLEVYN GENTLE BORDER DRESSING REACTED TO THE DRESSING. THIS PATIENT GOT A RED SKIN RASH IN THE AREA ALONGSIDE THE BORDER OF ALLEVYN GENTLE. THEY USED CORTISONE AND REPLACED WITH MEPILEX BORDER DRESSING.

  Patient problems: Hypersensitivity/Allergic reaction; Rash; Skin Irritation

  MAUDE report 10603524 ↗
• InjurySep 29, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT ONE PATIENT IN A SHORT TIME WHO HAD ALLEVYN GENTLE BORDER DRESSING REACTED TO THE DRESSING. THIS PATIENT HAD AN ITCH IN THE AREA ALONGSIDE THE BORDER OF ALLEVYN GENTLE. THEY USED CORTISONE AND REPLACED WITH MEPILEX BORDER DRESSING.

  Patient problems: Hypersensitivity/Allergic reaction; Itching Sensation; Skin Irritation

  MAUDE report 10603384 ↗
• MalfunctionJul 22, 2020Loss of or Failure to Bond; Loss of or Failure to Bond

  IT WAS REPORTED THAT ON REMOVAL OF THE SACRAL DRESSING, SOME PARTICLES OF SILICONE REMAINED ON THE PATIENT'S SKIN SURROUNDING THE WOUND. ON REMOVAL OF THE 15X15CM DRESSING, AGAIN, SOME PARTICLES OF SILICONE REMAINED ON THE PATIENT'S SKIN SURROUNDING THE WOUND. THE WOUNDS WERE BOTH CAVITIES AND THERE WAS RISK THE SILICONE COULD END UP IN THE WOUNDS. THESE OCCURRED ON DIFFERENT PATIENTS, ON DIFFERENT WARDS AND DIFFERENT SITES WITHIN THE TRUST. ON OPENING A NEW DRESSING 7.5X7.5CM, PARTS OF THE SILICONE REMAINED ON THE FILM COVER. IT IS UNKNOWN HOW MANY PATIENTS ARE INVOLVED. NO PATIENT HARM REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10311130 ↗
• InjuryJun 18, 2020Material Integrity Problem; Material Integrity Problem

  IT WAS REPORTED THAT PATIENT HAD LONG WOUND ISSUES AFTER ABDOMINOPLASTY. SHE HAD USED BOTH RENASYS AND PICO SATISFACTORILY. WOUND WAS HEALING WELL WITH DRESSING CHANGES USING WIC POLYMEM OCH MEPILEXBORDER DRESSING. DRESSING WAS CHANGED TO ALLEVYN GENTLE BORDER DUE TO CHANGE IN PROVIDER, BUT THE ALLEVYN WOULD NOT STICK TO THE SKIN. THE DRESSING FELL OF SEVERAL TIMES SO DRESSINGS HAD BE SENT WITH THE PATIENT TO TAKE HOME. DUE TO THE MALFUNCTION THE PATIENT HAD TO BE TAKEN BACK TO USE PREVIOUS COMPETITOR DRESSING AND IT STAYED IN PLACE FOR THE NEXT DRESSING CHANGE WITH NO PROBLEM. NO PATIENT HARM REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions; No Consequences Or Impact To Patient

  MAUDE report 10171274 ↗