AQUACEL FOAM PRO 422357Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 00768455157327), received between Oct 6, 2023 and Aug 21, 2025 — classified as 4 malfunctions.

The most frequently reported specific device problem is “Contamination /Decontamination Problem” (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 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• MalfunctionAug 21, 2025Delivered as Unsterile Product; Contamination /Decontamination Problem; Delivered as Unsterile Product; Contamination /Decontamination Problem

  THE DISTRIBUTOR REPORTED THAT IN AN INBOUND INSPECTION THERE WAS A BLACK SPOT FOUND INSIDE THE DRESSING. THE PRODUCT WAS NOT USED. NO PHOTOGRAPH WAS AVAILABLE AT THIS TIME.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22858943 ↗
• MalfunctionDec 21, 2023Delivered as Unsterile Product; Contamination /Decontamination Problem; Delivered as Unsterile Product; Contamination /Decontamination Problem

  IT WAS REPORTED THAT THERE WAS A HAIR INSIDE THE PRIMARY PACKAGING IDENTIFIED DURING THE LABELING PROCESS. THE PRODUCT WAS NOT USED BY PATIENT. THE PHOTOGRAPH DEPICTING THE ISSUE WAS RECEIVED FROM THE COMPLAINANT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18370750 ↗
• MalfunctionOct 6, 2023Difficult to Remove; Difficult to Remove

  IT WAS REPORTED BY DISTRIBUTOR THAT THE PATIENT HAD USED THE PRODUCT FOR SOME TIME WHICH WAS UNCLEAR SINCE WHEN. THE DRESSING CHANGE INTERVAL WAS UNKNOWN. IT WAS STATED THAT THE LAST TWO DRESSINGS WERE MORE DIFFICULT TO REMOVE AND PARTIALLY STUCK TO THE WOUND BED WHICH ON CHANGES WERE PAINFUL. THERE WAS PAIN IN THE WOUND BED DURING REMOVAL WHICH DISAPPEARED SHORTLY AFTER REMOVAL. THERE WAS NO BLEEDING. IT WAS UNKNOWN IF WOUND WAS SECRETING LESS. NO PHOTOGRAPH WAS AVAILABLE AT THIS TIME.

  Patient problems: Pain

  MAUDE report 17883863 ↗
• MalfunctionOct 6, 2023Difficult to Remove; Difficult to Remove

  IT WAS REPORTED BY DISTRIBUTOR THAT THE PATIENT HAD USED THE PRODUCT FOR SOME TIME WHICH WAS UNCLEAR SINCE WHEN. THE DRESSING CHANGE INTERVAL WAS UNKNOWN. IT WAS STATED THAT THE LAST TWO DRESSINGS WERE MORE DIFFICULT TO REMOVE AND PARTIALLY STUCK TO THE WOUND BED WHICH ON CHANGES WERE PAINFUL. THERE WAS PAIN IN THE WOUND BED DURING REMOVAL WHICH DISAPPEARED SHORTLY AFTER REMOVAL. THERE WAS NO BLEEDING. IT WAS UNKNOWN IF WOUND WAS SECRETING LESS. NO PHOTOGRAPH WAS AVAILABLE AT THIS TIME.

  Patient problems: Pain

  MAUDE report 17883862 ↗