AQUACEL AG+ ADVANTAGE 422605Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00768455169542), received between Jan 6, 2023 and Jul 22, 2025 — classified as 2 injuries, 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

Recent adverse event reports

The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• MalfunctionJul 22, 2025Delivered as Unsterile Product; Unsealed Device Packaging; Device Damaged Prior to Use; Delivered as Unsterile Product; Unsealed Device Packaging; Device Damaged Prior to Use

  THE DISTRIBUTOR REPORTED THAT THE PRIMARY PACKAGE OF ONE COMPANY'S DRESSING WAS NOT SEALED FROM ONE MARKET UNIT (MU). IT WAS STATED THAT THE END OF THE PACKAGE THAT WAS "NOT SEALED" WAS ON THE SIDE THAT ONE WOULD NOT NORMALLY OPEN, WHICH MADE THE DRESSING JUST FALL OUT ON ONE END. THE END USER STILL HAD THE ORIGINAL PACKAGING AND DRESSING. THIS DRESSING WAS NOT APPLIED TO ANY PATIENT. NO PHOTO WAS AVAILABLE AT THAT TIME.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22563085 ↗
• InjuryApr 28, 2023Improper or Incorrect Procedure or Method; Improper or Incorrect Procedure or Method

  TO DATE NO ADDITIONAL PATIENT OR EVENT DETAILS HAVE BEEN RECEIVED.

  Patient problems: Blister; Erythema; Hypersensitivity/Allergic reaction; Itching Sensation; Skin Discoloration; Skin Inflammation/ Irritation

  MAUDE report 16832926 ↗
• InjuryJan 6, 2023Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THAT REMOVAL OF ONE DRESSING OUT OF MARKET UNIT BOX OF DRESSINGS "STRIPPED" THE PERI-WOUND SKIN CAUSING IT TO LOOK "IRRITATED" TO ONE SIDE OF THE INCISION WHICH MIGHT BE A KNEE INCISION. THE PRODUCT WAS USED ON PATIENT BY AN ORTHOPEDIC SURGEON WHO WAS NEW TO PRODUCT. THE DOCTOR ASKED IF THE ISSUE WAS DUE AN ALLERGIC REACTION TO THE COMPANY¿S PRODUCT ON THE DRESSING HOWEVER THE ISSUE DID NOT OCCUR EVERYWHERE BUT APPEARS TO BE PRIMARILY TO ONE SIDE OF THE INCISION. ONE WOULD NOT EXPECT THIS PATTERN IF IT WERE AN ALLERGIC REACTION. IT WAS REPORTED THAT IT APPEARED THAT PERHAPS THE DRESSING IN USE WAS TOO SMALL FOR THE INCISION WHICH WOULD HAVE NECESSITATED STRETCHING THE DRESSING TO FIT THE WOUND CAUSING TENSION ON THE PERI-WOUND AREA. IT WAS UNKNOWN HOW LONG THE DRESSING WAS IN PLACE, WHAT ANGLE THE APPENDAGE WAS WHEN THE DRESSING WAS APPLIED, OR IF ANY PRODUCTS WERE USED TO THE SKIN UNDER THE DRESSING. IT WAS NOT CONFIRMED IF THE DRESSING WAS DIFFICULT TO REMOVE FROM THE SKIN. THE PATIENT WAS NOT HOSPITALIZED REGARDING THE ISSUE. NO OUTCOME INFORMATION WAS AVAILABLE, AND IT WAS UNKNOWN IF THE SAME DRESSING WAS RE-APPLIED. PHOTOGRAPHS ASSOCIATED WITH THE ISSUE WERE RE

  Patient problems: Skin Inflammation/ Irritation; Tissue Breakdown

  MAUDE report 16110671 ↗