AQUACEL AG+ ADVANTAGE 422299Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00768455154371), received between Jun 1, 2022 and Jun 1, 2022 — classified as 1 malfunction.

The most frequently reported specific device problem is “Difficult to Remove” (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 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• MalfunctionJun 1, 2022Difficult to Remove; Difficult to Remove

  IT WAS REPORTED THAT END USER WAS AN ADULT MALE WHO HAD A RIGHT SHIN WOUND EIGHT INCHES ABOVE HIS ANKLE. THE END USER AND HIS WIFE REPORTED THAT INITIALLY THEY HAD THE ONE DRESSING APPLIED OUT OF A MARKET UNIT OF DRESSINGS AT THE WOUND CLINIC ON (B)(6) 2022. LATER, HE REMOVED THE DRESSING AT HOME ON (B)(6) 2022, AS DIRECTED BY THE WOUND CLINIC. THE WIFE OF END USER CALLED THE CLINIC BECAUSE EVEN THOUGH THE DRESSING WAS MOIST IT WAS ADHERING TO THE WOUND AND THEY WERE DIRECTED TO MOISTEN THE DRESSING WITH SALINE WHICH HE DID AND THEN REMOVED THE DRESSING EASILY. HE ALSO CLEANED THE WOUND WITH SALINE THEN APPLIED NEW DRESSING WHICH WAS PROVIDED BY THE WOUND CLINIC. HE DID NOT APPLY ANY OTHER PRODUCTS DIRECTLY TO THE WOUND. HE COVERED THE DRESSING WITH OTHER COMPANY¿S ABSORBENT FOAM DRESSING. HE WAS AWAKE FROM SLEEP THAT NIGHT DUE TO INTENSE STINGING SENSATION TO THE RIGHT LEG SHIN WOUND. THE END USER AND HIS WIFE WERE RECOMMENDED NOT TO USE PRODUCT THAT CAUSES STINGING TO THE WOUND AND TO REPORT THIS ISSUE TO WOUND CLINIC. A FOLLOW UP CALL WAS MADE TO END USER. HE WAS ON HIS WAY TO THE WOUND CLINIC AS PER THE DIRECTIONS. MULTIPLE ATTEMPTS TO CALL WITH OUTBOUND CALL TO END USER TWICE

  Patient problems: Burning Sensation

  MAUDE report 14565115 ↗