AQUACEL FOAM 420680Recalls & reported problems

Summary

The FDA's MAUDE database contains 15 adverse event reports that list this exact device (DI 00768455127115), received between Dec 3, 2021 and Jun 9, 2025 — classified as 1 injury, 14 malfunctions.

The most frequently reported specific device problem is “Contamination /Decontamination Problem” (10 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 15 most recent of 15 reports, in the reporter's own words as published by the FDA.

• MalfunctionJun 9, 2025Delivered as Unsterile Product; Contamination /Decontamination Problem; Delivered as Unsterile Product; Contamination /Decontamination Problem

  TO DATE, ADDITIONAL PATIENT OR EVENT DETAILS WERE RECEIVED WHICH HAVE BEEN ADDED IN H11. (ADDL MFG NARRATIVE)

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22170362 ↗
• MalfunctionJun 9, 2025Delivered as Unsterile Product; Contamination /Decontamination Problem; Delivered as Unsterile Product; Contamination /Decontamination Problem

  TO DATE, ADDITIONAL PATIENT OR EVENT DETAILS WERE RECEIVED WHICH HAVE BEEN ADDED IN H11 (ADDL MFG NARRATIVE)

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22170359 ↗
• MalfunctionJun 9, 2025Delivered as Unsterile Product; Contamination /Decontamination Problem; Delivered as Unsterile Product; Contamination /Decontamination Problem

  TO DATE, ADDITIONAL PATIENT OR EVENT DETAILS WERE RECEIVED WHICH HAVE BEEN ADDED IN H11 (ADDL MFG NARRATIVE)

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22170355 ↗
• MalfunctionJun 9, 2025Delivered as Unsterile Product; Contamination /Decontamination Problem; Delivered as Unsterile Product; Contamination /Decontamination Problem

  THE WOUND CARE NURSE REPORTED THAT SHE HAD DISCOVERED AN EXTRA FOREIGN OBJECT UNDER THE SILICONE BORDER OF THE BANDAGE. THE PRODUCT HAD NOT BEEN USED. A PHOTOGRAPH DEPICTING THE ISSUE WAS RECEIVED FROM THE COMPLAINANT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22170354 ↗
• MalfunctionJun 9, 2025Delivered as Unsterile Product; Contamination /Decontamination Problem; Delivered as Unsterile Product; Contamination /Decontamination Problem

  TO DATE, ADDITIONAL PATIENT OR EVENT DETAILS WERE RECEIVED WHICH HAVE BEEN ADDED IN H11. (ADDL MFG NARRATIVE)

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22170351 ↗
• MalfunctionJun 9, 2025Delivered as Unsterile Product; Contamination /Decontamination Problem; Delivered as Unsterile Product; Contamination /Decontamination Problem

  THE WOUND CARE NURSE REPORTED THAT SHE HAD DISCOVERED AN EXTRA FOREIGN OBJECT UNDER THE SILICONE BORDER OF THE BANDAGE. THE PRODUCT HAD NOT BEEN USED. A PHOTOGRAPH DEPICTING THE ISSUE WAS RECEIVED FROM THE COMPLAINANT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22170349 ↗
• MalfunctionJun 9, 2025Delivered as Unsterile Product; Contamination /Decontamination Problem; Delivered as Unsterile Product; Contamination /Decontamination Problem

  TO DATE, ADDITIONAL PATIENT OR EVENT DETAILS WERE RECEIVED WHICH HAVE BEEN ADDED IN H11. (ADDL MFG NARRATIVE)

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22170348 ↗
• MalfunctionJun 9, 2025Delivered as Unsterile Product; Contamination /Decontamination Problem; Delivered as Unsterile Product; Contamination /Decontamination Problem

  THE WOUND CARE NURSE REPORTED THAT SHE HAD DISCOVERED AN EXTRA FOREIGN OBJECT UNDER THE SILICONE BORDER OF THE BANDAGE. THE PRODUCT HAD NOT BEEN USED. A PHOTOGRAPH DEPICTING THE ISSUE WAS RECEIVED FROM THE COMPLAINANT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22170347 ↗
• MalfunctionJun 9, 2025Delivered as Unsterile Product; Contamination /Decontamination Problem; Delivered as Unsterile Product; Contamination /Decontamination Problem

  TO DATE, ADDITIONAL PATIENT OR EVENT DETAILS WERE RECEIVED WHICH HAVE BEEN ADDED IN H11 (ADDL MFG NARRATIVE).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22170346 ↗
• MalfunctionJun 9, 2025Delivered as Unsterile Product; Contamination /Decontamination Problem; Delivered as Unsterile Product; Contamination /Decontamination Problem

  THE WOUND CARE NURSE REPORTED THAT SHE HAD DISCOVERED AN EXTRA FOREIGN OBJECT UNDER THE SILICONE BORDER OF THE BANDAGE. THE PRODUCT HAD NOT BEEN USED. A PHOTOGRAPH DEPICTING THE ISSUE WAS RECEIVED FROM THE COMPLAINANT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22170345 ↗
• MalfunctionMay 15, 2025Difficult to Remove; Difficult to Remove

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

  Patient problems: Tissue Breakdown

  MAUDE report 22026284 ↗
• MalfunctionSep 26, 2022Patient-Device Incompatibility; Patient-Device Incompatibility

  THE NURSE REPORTED TO THE COMPANY'S EMPLOYEE THAT SHE HAD TO CEASE KNOWN COMPANY¿S DRESSING AND COMPANY¿S ANOTHER DRESSING EVALUATION ON A DIABETIC PATIENT WHO HAD FOOT PLANTAR ULCER. THE DRESSING WAS REPLACED, AND THE PATIENT WAS SCHEDULED FOR REVIEW ON (B)(6) 2022. FURTHERMORE, IT WAS MENTIONED THAT THE EXUDATE WAS COPIOUS OVER THREE SUBSEQUENT CHANGES OF DRESSING AND THAT IT DID NOT MANAGE THIS AT ALL. IT WAS STATED THAT THE EXUDATE INCREASED WHEN THEY STARTED USING THE FIRST DRESSING AND IT APPEARED THAT THE SECOND DRESSING APPLIED DID NOT HANDLE THE INCREASED EXUDATE AT ALL. THE TISSUE INTEGRITY HAD DETERIORATED, AND THE PERI WOUND WAS MACERATED. MEDICAL ATTENTION WAS REQUIRED, AND NEW DRESSINGS HAD TO BE APPLIED AS PER THAT. PERI WOUND MACERATION AND EXUDATE INCREASED WITH EACH NEW DRESSING. THE DRESSING WAS THE ONLY VARIANCE DURING THIS TIME. SHE FELT THAT THE PATIENT HAD BEEN COMPLIANT WITH HER TREATMENT. THE DURATION OF USE WAS UNKNOWN. NO PHOTOGRAPH IS AVAILABLE AT THIS TIME.

  Patient problems: Tissue Breakdown

  MAUDE report 15482745 ↗
• MalfunctionSep 26, 2022Patient-Device Incompatibility; Patient-Device Incompatibility

  THE NURSE REPORTED TO THE COMPANY'S EMPLOYEE THAT SHE HAD TO CEASE KNOWN COMPANY¿S DRESSING AND COMPANY¿S ANOTHER DRESSING EVALUATION ON A DIABETIC PATIENT WHO HAD FOOT PLANTAR ULCER. THE DRESSING WAS REPLACED, AND THE PATIENT WAS SCHEDULED FOR REVIEW ON (B)(6) 2022. FURTHERMORE, IT WAS MENTIONED THAT THE EXUDATE WAS COPIOUS OVER THREE SUBSEQUENT CHANGES OF DRESSING AND THAT IT DID NOT MANAGE THIS AT ALL. IT WAS STATED THAT THE EXUDATE INCREASED WHEN THEY STARTED USING THE FIRST DRESSING AND IT APPEARED THAT THE SECOND DRESSING APPLIED DID NOT HANDLE THE INCREASED EXUDATE AT ALL. THE TISSUE INTEGRITY HAD DETERIORATED, AND THE PERI WOUND WAS MACERATED. MEDICAL ATTENTION WAS REQUIRED, AND NEW DRESSINGS HAD TO BE APPLIED AS PER THAT. PERI WOUND MACERATION AND EXUDATE INCREASED WITH EACH NEW DRESSING. THE DRESSING WAS THE ONLY VARIANCE DURING THIS TIME. SHE FELT THAT THE PATIENT HAD BEEN COMPLIANT WITH HER TREATMENT. THE DURATION OF USE WAS UNKNOWN. NO PHOTOGRAPH IS AVAILABLE AT THIS TIME.

  Patient problems: Tissue Breakdown

  MAUDE report 15482743 ↗
• MalfunctionSep 26, 2022Patient-Device Incompatibility; Patient-Device Incompatibility

  THE NURSE REPORTED TO THE COMPANY'S EMPLOYEE THAT SHE HAD TO CEASE KNOWN COMPANY¿S DRESSING AND COMPANY¿S ANOTHER DRESSING EVALUATION ON A DIABETIC PATIENT WHO HAD FOOT PLANTAR ULCER. THE DRESSING WAS REPLACED, AND THE PATIENT WAS SCHEDULED FOR REVIEW ON (B)(6) 2022. FURTHERMORE, IT WAS MENTIONED THAT THE EXUDATE WAS COPIOUS OVER THREE SUBSEQUENT CHANGES OF DRESSING AND THAT IT DID NOT MANAGE THIS AT ALL. IT WAS STATED THAT THE EXUDATE INCREASED WHEN THEY STARTED USING THE FIRST DRESSING AND IT APPEARED THAT THE SECOND DRESSING APPLIED DID NOT HANDLE THE INCREASED EXUDATE AT ALL. THE TISSUE INTEGRITY HAD DETERIORATED, AND THE PERI WOUND WAS MACERATED. MEDICAL ATTENTION WAS REQUIRED, AND NEW DRESSINGS HAD TO BE APPLIED AS PER THAT. PERI WOUND MACERATION AND EXUDATE INCREASED WITH EACH NEW DRESSING. THE DRESSING WAS THE ONLY VARIANCE DURING THIS TIME. SHE FELT THAT THE PATIENT HAD BEEN COMPLIANT WITH HER TREATMENT. THE DURATION OF USE WAS UNKNOWN. NO PHOTOGRAPH IS AVAILABLE AT THIS TIME.

  Patient problems: Tissue Breakdown

  MAUDE report 15482735 ↗
• InjuryDec 3, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE END USER REPORTED THAT THE WOUND DRESSING WAS USED AS SECONDARY DRESSING. IT WAS ALLEGED THAT IT CAUSED ALLERGY AND IRRITATION. HOWEVER, AS PER PHOTOGRAPH PROVIDED AND CLINICAL REVIEW, IT WAS DETERMINED THAT THE PHOTO DID NOT REPRESENT AN ALLERGIC RESPONSE. INSTEAD, IT SHOWED WHAT APPEARED TO BE TISSUE DAMAGE AT THE AREA OF THE DRESSING WHERE THE SILICONE MEETS THE HYDRO FIBER. THERE WAS REDNESS AND MACERATED TISSUE CHARACTERISTICS, AS WELL AS FULL THICKNESS TISSUE DAMAGE AS PER THE PHOTOGRAPH PROVIDED.

  Patient problems: Erythema; Tissue Breakdown

  MAUDE report 12923202 ↗