AQUACEL AG 412011Recalls & reported problems

Summary

The FDA's MAUDE database contains 13 adverse event reports that list this exact device (DI 00768455124299), received between Jun 29, 2017 and Mar 27, 2025 — classified as 5 injuries, 8 malfunctions.

The most frequently reported specific device problem is “Delivered as Unsterile Product” (7 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 13 most recent of 13 reports, in the reporter's own words as published by the FDA.

• MalfunctionMar 27, 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 DRESSING PACKAGE WAS UNSTITCHED/SHREDDED AND WAS FOUND DURING UNDRESSING. THE PRODUCT WAS NOT USED. PHOTOGRAPHS DEPICTING THE ISSUE WERE RECEIVED FROM THE COMPLAINANT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21705175 ↗
• MalfunctionMar 27, 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 DRESSING PACKAGE WAS UNSTITCHED/SHREDDED AND WAS FOUND DURING UNDRESSING. THE PRODUCT WAS NOT USED. PHOTOGRAPHS DEPICTING THE ISSUE WERE RECEIVED FROM THE COMPLAINANT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21705174 ↗
• MalfunctionMar 27, 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 DRESSING PACKAGE WAS UNSTITCHED/SHREDDED AND WAS FOUND DURING UNDRESSING. THE PRODUCT WAS NOT USED. PHOTOGRAPHS DEPICTING THE ISSUE WERE RECEIVED FROM THE COMPLAINANT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21705173 ↗
• MalfunctionMar 27, 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 DRESSING PACKAGE WAS UNSTITCHED/SHREDDED AND WAS FOUND DURING UNDRESSING. THE PRODUCT WAS NOT USED. PHOTOGRAPHS DEPICTING THE ISSUE WERE RECEIVED FROM THE COMPLAINANT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21705172 ↗
• MalfunctionMar 27, 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 DRESSING PACKAGE WAS UNSTITCHED/SHREDDED AND WAS FOUND DURING UNDRESSING. THE PRODUCT WAS NOT USED. PHOTOGRAPHS DEPICTING THE ISSUE WERE RECEIVED FROM THE COMPLAINANT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21705171 ↗
• MalfunctionMay 3, 2024Difficult to Remove; Difficult to Remove

  THE CUSTOMER HCP (HEALTH CARE PROFESSIONAL) REPORTED THE COMPLAINT TO COMPANY'S REPRESENTATIVE THAT AT THE TIME OF REMOVAL OF THE DEVICE IT APPEARED TO BE FUSED WITH THE SKIN. ALTHOUGH REMOVAL WAS VERY DIFFICULT, IT WAS CAUSING PAIN TO THE PATIENT AT THE SITE OF THE OPERATION AND SUFFERING OF THE AFFECTED SKIN. IT DID NOT PROVOKE SKIN OUTCOMES. THE DRESSING WAS PLACED ON A TOTAL SHOULDER ENDOPROSTHESIS (TEP) RIGHT SHOULDER ON (B)(6) 2024 AND WAS REMOVED ON (B)(6) 2024. NO PHOTO IS AVAILABLE AT THIS TIME.

  Patient problems: Pain

  MAUDE report 19236053 ↗
• MalfunctionApr 12, 2024Delivered as Unsterile Product; Contamination /Decontamination Problem; Delivered as Unsterile Product; Contamination /Decontamination Problem

  THE DISTRIBUTOR REPORTED THAT COMPLAINT RECEIVED FROM HOSPITAL ABOUT PRODUCT DISCOLORATION, PART OF DRESSING COLOR WAS DARKENED. THE PRODUCT WAS NOT USED ON PATIENT. PHOTOGRAPHS DEPICTING THE ISSUE WERE RECEIVED FROM THE COMPLAINANT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19094778 ↗
• InjuryMar 17, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED BY END USER¿S WIFE THAT AQUACEL AG SURGICAL DRESSING WAS APPLIED TO THE END USER¿S LEFT KNEE INCISION ON SIXTH OF (B)(6) 2021 AND WITHIN ONE DAY, REDNESS STARTED AT INCISION SITE AND RADIATED TO GROIN AND TO ANKLE. HOWEVER, ACCORDING TO THE PHOTOS RECEIVED, IT APPEARED THAT THE REDNESS EXTENDED TOWARD ANKLE AND DID NOT EXTEND TO GROIN. THE END USER WAS STARTED ON PENICILLIN PRESCRIBED. THE DRESSING WAS REMOVED ON TENTH OF (B)(6) 2021 AND DISCONTINUED TO USE. BY THIRTEENTH OF (B)(6) 2021, REDNESS HAD COMPLETELY RESOLVED. PHOTOGRAPH DEPICTING THE ISSUE WAS RECEIVED FROM THE COMPLAINANT.

  Patient problems: Erythema; Hypersensitivity/Allergic reaction

  MAUDE report 13801262 ↗
• InjuryNov 20, 2019Use of Device Problem; Use of Device Problem

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

  Patient problems: Cellulitis; Fluid Discharge; Tissue Damage

  MAUDE report 9351043 ↗
• InjuryNov 20, 2019Use of Device Problem; Use of Device Problem

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

  Patient problems: Cellulitis; Fluid Discharge; Tissue Damage

  MAUDE report 9351011 ↗
• MalfunctionAug 1, 2017Delivered as Unsterile Product; Device Contamination with Chemical or Other Material; Delivered as Unsterile Product; Device Contamination with Chemical or Other Material

  THE END USER REPORTED THAT UPON OPENING A SEALED AQUACEL AG SURGICAL COVER DRESSING, A BROWN OBJECT ABOUT (0.2 CM X .05 CM) IN SIZE WAS NOTED. THIS APPEARED TO BE AN INSECT AND SEVERAL TINY BROWN DOTS WERE SEEN ON THE GAUZE PAD OF THE DRESSING. THE DRESSING WAS NOT USED BY THE PATIENT. A PHOTOGRAPH WAS PROVIDED BY THE END USER DEPICTING THE REPORTED EVENT. NO FURTHER DETAILS HAVE BEEN PROVIDED.

  Patient problems: No Patient Involvement

  MAUDE report 6758634 ↗
• InjuryJul 11, 2017Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE ORTHOPEDIC PHYSICIAN REPORTED THAT ON (B)(6) 2017, HE APPLIED AN AQUACEL AG SURGICAL COVER DRESSING POST-OPERATIVELY FOLLOWING LEFT HIP SURGERY. THE PHYSICIAN INDICATED THAT AFTER SURGERY HE CLEANED THE WOUND WITH DURAPREP AND LOBAN. IT WAS REPORTED THAT ON (B)(6) 2017, WHILE CHECKING ON THE SURGICAL WOUND, THE PHYSICIAN NOTED NECROSIS OF THE PATIENT'S SKIN WHERE THE SKIN WAS IN CONTACT WITH THE DRESSING. IT WAS FURTHER REPORTED THAT THERE WAS BLISTERING AND BRUISES ON THE SKIN SURROUNDING THE WOUND. THE NECROTIC SKIN WAS REMOVED AND THE PHYSICIAN APPLIED ROFOCINE AND FIXOMULL. PHOTOS WERE PROVIDED REGARDING THE REPORTED COMPLAINT ISSUE. NO FURTHER DETAILS HAVE BEEN PROVIDED.

  Patient problems: Bruise/Contusion; Necrosis; Skin Irritation

  MAUDE report 6704607 ↗
• InjuryJun 29, 2017Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PRODUCT WAS PLACED ON THE END USER'S RIGHT HIP FOLLOWING TOTAL HIP REPLACEMENT ON (B)(6) 2017. THE SKIN WAS HEALTHY UPON REMOVAL OF THE DRESSING ON (B)(6) 2017. NO ADDITIONAL DRESSING WAS ORDERED TO BE PLACED ON THE AREA. ON THE EVENING OF (B)(6) 2017, THE END USER DEVELOPED SEVERE ITCHING AND THE SKIN ADJACENT TO HER INCISION HAD BECOME RED AND INFLAMED BUT WITHOUT BLISTERING OR WEEPING. IT BECAME HOT AND ITCHY AND SPREAD OVER THE ENTIRE DRESSING CONTACT SITE AND BEYOND. SHE NOTIFIED HER SURGEON AND WAS DIRECTED TO GO TO THE EMERGENCY DEPARTMENT ON (B)(6) 2017 IN WHICH SHE WAS ADMITTED. BENADRYL WAS ADMINISTERED INTRAVENOUSLY AND SHE HAD A NEEDLE BIOPSY OF THE RIGHT HIP JOINT ON (B)(6) 2017 TO RULE OUT INFECTION. THE BIOPSY RESULTS SHOWED NO GROWTH. SHE WAS DISCHARGED WITH A DIAGNOSIS OF CELLULITIS AND AN ALLERGIC REACTION TO THE HYDROCOLLOID BORDER. SHE WAS PRESCRIBED ORAL KEFLEX FOR SEVEN DAYS. SHE REPORTS THE REDNESS HAS DECREASED WITH A LITTLE ITCHING AND SAYS THE SKIN FEELS BUMPY, LEATHERY AND DRY. PHOTOS DEPICTING THE REPORTED COMPLAINT ISSUE WERE PROVIDED REVIEW. NO FURTHER DETAILS HAVE BEEN PROVIDED.

  Patient problems: Cellulitis; Itching Sensation; Skin Inflammation

  MAUDE report 6676992 ↗