AQUACEL FOAM 421561Recalls & reported problems

Summary

The FDA's MAUDE database contains 10 adverse event reports that list this exact device (DI 00768455142248), received between Feb 7, 2025 and Feb 7, 2025 — classified as 10 malfunctions.

The most frequently reported specific device problem is “Difficult to Remove” (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 16, 2026.

Most reported problems

Recent adverse event reports

The 10 most recent of 10 reports, in the reporter's own words as published by the FDA.

• MalfunctionFeb 7, 2025Difficult to Remove; Difficult to Remove

  THE END USER REPORTED THAT SHE EXPERIENCED THE BANDAGE BEEN TOO ADHESIVE AND STUCK TOO WELL TO THE SURROUNDING SKIN AND DID NOT CAME OFF. ALL PRODUCTS OUT OF BOX OF TEN HAD BEEN IMPACTED AND USED BY PATIENT. THEY HAD USED THE PRODUCT FOR A LONG TIME, AND NO PREPARATION WAS USED. THE DURATION OF USE WAS NORMALLY UP TO ONE WEEK BUT DEPENDED ON SEVERAL THINGS. THERE WAS NEITHER HARM ALLEGED TO PATIENT NOR ANY DAMAGE TO PROPERTY. PHOTOGRAPHS DEPICTING THE LOT NUMBER OF THE PRODUCT WERE RECEIVED FROM THE COMPLAINANT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21332797 ↗
• MalfunctionFeb 7, 2025Difficult to Remove; Difficult to Remove

  THE END USER REPORTED THAT SHE EXPERIENCED THE BANDAGE BEEN TOO ADHESIVE AND STUCK TOO WELL TO THE SURROUNDING SKIN AND DID NOT CAME OFF. ALL PRODUCTS OUT OF BOX OF TEN HAD BEEN IMPACTED AND USED BY PATIENT. THEY HAD USED THE PRODUCT FOR A LONG TIME, AND NO PREPARATION WAS USED. THE DURATION OF USE WAS NORMALLY UP TO ONE WEEK BUT DEPENDED ON SEVERAL THINGS. THERE WAS NEITHER HARM ALLEGED TO PATIENT NOR ANY DAMAGE TO PROPERTY. PHOTOGRAPHS DEPICTING THE LOT NUMBER OF THE PRODUCT WERE RECEIVED FROM THE COMPLAINANT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21332796 ↗
• MalfunctionFeb 7, 2025Difficult to Remove; Difficult to Remove

  THE END USER REPORTED THAT SHE EXPERIENCED THE BANDAGE BEEN TOO ADHESIVE AND STUCK TOO WELL TO THE SURROUNDING SKIN AND DID NOT CAME OFF. ALL PRODUCTS OUT OF BOX OF TEN HAD BEEN IMPACTED AND USED BY PATIENT. THEY HAD USED THE PRODUCT FOR A LONG TIME, AND NO PREPARATION WAS USED. THE DURATION OF USE WAS NORMALLY UP TO ONE WEEK BUT DEPENDED ON SEVERAL THINGS. THERE WAS NEITHER HARM ALLEGED TO PATIENT NOR ANY DAMAGE TO PROPERTY. PHOTOGRAPHS DEPICTING THE LOT NUMBER OF THE PRODUCT WERE RECEIVED FROM THE COMPLAINANT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21332795 ↗
• MalfunctionFeb 7, 2025Difficult to Remove; Difficult to Remove

  THE END USER REPORTED THAT SHE EXPERIENCED THE BANDAGE BEEN TOO ADHESIVE AND STUCK TOO WELL TO THE SURROUNDING SKIN AND DID NOT CAME OFF. ALL PRODUCTS OUT OF BOX OF TEN HAD BEEN IMPACTED AND USED BY PATIENT. THEY HAD USED THE PRODUCT FOR A LONG TIME, AND NO PREPARATION WAS USED. THE DURATION OF USE WAS NORMALLY UP TO ONE WEEK BUT DEPENDED ON SEVERAL THINGS. THERE WAS NEITHER HARM ALLEGED TO PATIENT NOR ANY DAMAGE TO PROPERTY. PHOTOGRAPHS DEPICTING THE LOT NUMBER OF THE PRODUCT WERE RECEIVED FROM THE COMPLAINANT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21332794 ↗
• MalfunctionFeb 7, 2025Difficult to Remove; Difficult to Remove

  THE END USER REPORTED THAT SHE EXPERIENCED THE BANDAGE BEEN TOO ADHESIVE AND STUCK TOO WELL TO THE SURROUNDING SKIN AND DID NOT CAME OFF. ALL PRODUCTS OUT OF BOX OF TEN HAD BEEN IMPACTED AND USED BY PATIENT. THEY HAD USED THE PRODUCT FOR A LONG TIME, AND NO PREPARATION WAS USED. THE DURATION OF USE WAS NORMALLY UP TO ONE WEEK BUT DEPENDED ON SEVERAL THINGS. THERE WAS NEITHER HARM ALLEGED TO PATIENT NOR ANY DAMAGE TO PROPERTY. PHOTOGRAPHS DEPICTING THE LOT NUMBER OF THE PRODUCT WERE RECEIVED FROM THE COMPLAINANT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21332793 ↗
• MalfunctionFeb 7, 2025Difficult to Remove; Difficult to Remove

  THE END USER REPORTED THAT SHE EXPERIENCED THE BANDAGE BEEN TOO ADHESIVE AND STUCK TOO WELL TO THE SURROUNDING SKIN AND DID NOT CAME OFF. ALL PRODUCTS OUT OF BOX OF TEN HAD BEEN IMPACTED AND USED BY PATIENT. THEY HAD USED THE PRODUCT FOR A LONG TIME, AND NO PREPARATION WAS USED. THE DURATION OF USE WAS NORMALLY UP TO ONE WEEK BUT DEPENDED ON SEVERAL THINGS. THERE WAS NEITHER HARM ALLEGED TO PATIENT NOR ANY DAMAGE TO PROPERTY. PHOTOGRAPHS DEPICTING THE LOT NUMBER OF THE PRODUCT WERE RECEIVED FROM THE COMPLAINANT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21332792 ↗
• MalfunctionFeb 7, 2025Difficult to Remove; Difficult to Remove

  THE END USER REPORTED THAT SHE EXPERIENCED THE BANDAGE BEEN TOO ADHESIVE AND STUCK TOO WELL TO THE SURROUNDING SKIN AND DID NOT CAME OFF. ALL PRODUCTS OUT OF BOX OF TEN HAD BEEN IMPACTED AND USED BY PATIENT. THEY HAD USED THE PRODUCT FOR A LONG TIME, AND NO PREPARATION WAS USED. THE DURATION OF USE WAS NORMALLY UP TO ONE WEEK BUT DEPENDED ON SEVERAL THINGS. THERE WAS NEITHER HARM ALLEGED TO PATIENT NOR ANY DAMAGE TO PROPERTY. PHOTOGRAPHS DEPICTING THE LOT NUMBER OF THE PRODUCT WERE RECEIVED FROM THE COMPLAINANT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21332791 ↗
• MalfunctionFeb 7, 2025Difficult to Remove; Difficult to Remove

  THE END USER REPORTED THAT SHE EXPERIENCED THE BANDAGE BEEN TOO ADHESIVE AND STUCK TOO WELL TO THE SURROUNDING SKIN AND DID NOT CAME OFF. ALL PRODUCTS OUT OF BOX OF TEN HAD BEEN IMPACTED AND USED BY PATIENT. THEY HAD USED THE PRODUCT FOR A LONG TIME, AND NO PREPARATION WAS USED. THE DURATION OF USE WAS NORMALLY UP TO ONE WEEK BUT DEPENDED ON SEVERAL THINGS. THERE WAS NEITHER HARM ALLEGED TO PATIENT NOR ANY DAMAGE TO PROPERTY. PHOTOGRAPHS DEPICTING THE LOT NUMBER OF THE PRODUCT WERE RECEIVED FROM THE COMPLAINANT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21332790 ↗
• MalfunctionFeb 7, 2025Difficult to Remove; Difficult to Remove

  THE END USER REPORTED THAT SHE EXPERIENCED THE BANDAGE BEEN TOO ADHESIVE AND STUCK TOO WELL TO THE SURROUNDING SKIN AND DID NOT CAME OFF. ALL PRODUCTS OUT OF BOX OF TEN HAD BEEN IMPACTED AND USED BY PATIENT. THEY HAD USED THE PRODUCT FOR A LONG TIME, AND NO PREPARATION WAS USED. THE DURATION OF USE WAS NORMALLY UP TO ONE WEEK BUT DEPENDED ON SEVERAL THINGS. THERE WAS NEITHER HARM ALLEGED TO PATIENT NOR ANY DAMAGE TO PROPERTY. PHOTOGRAPHS DEPICTING THE LOT NUMBER OF THE PRODUCT WERE RECEIVED FROM THE COMPLAINANT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21332785 ↗
• MalfunctionFeb 7, 2025Difficult to Remove; Difficult to Remove

  THE END USER REPORTED THAT SHE EXPERIENCED THE BANDAGE BEEN TOO ADHESIVE AND STUCK TOO WELL TO THE SURROUNDING SKIN AND DID NOT CAME OFF. ALL PRODUCTS OUT OF BOX OF TEN HAD BEEN IMPACTED AND USED BY PATIENT. THEY HAD USED THE PRODUCT FOR A LONG TIME, AND NO PREPARATION WAS USED. THE DURATION OF USE WAS NORMALLY UP TO ONE WEEK BUT DEPENDED ON SEVERAL THINGS. THERE WAS NEITHER HARM ALLEGED TO PATIENT NOR ANY DAMAGE TO PROPERTY. PHOTOGRAPHS DEPICTING THE LOT NUMBER OF THE PRODUCT WERE RECEIVED FROM THE COMPLAINANT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21332784 ↗