AQUACEL AG 412012Recalls & reported problems
Convatec, Purchasing Department · AQUACEL AG SCD DRS 9X35CM (1X10PK) US · Class U
All models of AQUACEL AG+ (9)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 4
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 00768455124275), received between Nov 16, 2021 and Jul 16, 2024 — classified as 4 malfunctions.
The most frequently reported specific device problem is “Nonstandard Device” (3 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.
Reports received per month
Most reported problems
Device problems
- Nonstandard Device3
- Patient-Device Incompatibility1
Patient problems
- Hypersensitivity/Allergic reaction3
- No Clinical Signs, Symptoms or Conditions1
Recent adverse event reports
The 4 most recent of 4 reports, in the reporter's own words as published by the FDA.
MalfunctionJul 16, 2024Nonstandard Device; Nonstandard Device
TO DATE NO ADDITIONAL PATIENT OR EVENT DETAILS HAVE BEEN RECEIVED.
Patient problems: Hypersensitivity/Allergic reaction
MAUDE report 19748276 ↗MalfunctionJul 16, 2024Nonstandard Device; Nonstandard Device
THE DISTRIBUTOR REPORTED THAT, THEY RECEIVED A COMPLAINT FROM HOSPITAL ABOUT A PATIENT HAD ORTHOPEDIC SURGERY. THE PATIENT WORE THE COMPANY¿S DRESSING AS POSTOPERATIVE PATCH AND NO OTHER PRODUCTS WERE APPLIED. WHEN THE PATIENT WAS REPLACED A DRESSING WITH A NEW ONE, FOUND THAT THE PATIENT'S ORIGINAL PATCH HAD AN OBVIOUS WHITE AREA, WHICH SEEMED TO CONTAIN NO SILVER (AG), AND THE FUNCTION OF ABSORBING EXUDATE WAS NOT VERY GOOD, SO THERE WAS A REACTION. ADDITIONALLY CLARIFIED THAT THE DRESSING WAS USED UP TO THREE DAYS AND IT WAS THE FIRST TIME TO USE IT AFTER SURGERY. THE REACTION WAS RESOLVED AND THE PATIENT DOES NOT HAVE ANY OTHER DIAGNOSES. PHOTOGRAPHS DEPICTING THE ISSUE WERE RECEIVED FROM THE COMPLAINANT.
Patient problems: Hypersensitivity/Allergic reaction
MAUDE report 19748275 ↗MalfunctionJul 16, 2024Nonstandard Device; Nonstandard Device
TO DATE NO ADDITIONAL PATIENT OR EVENT DETAILS HAVE BEEN RECEIVED.
Patient problems: Hypersensitivity/Allergic reaction
MAUDE report 19748274 ↗MalfunctionNov 16, 2021Patient-Device Incompatibility; Patient-Device Incompatibility
TO DATE NO ADDITIONAL PATIENT OR EVENT DETAILS HAVE BEEN RECEIVED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12818720 ↗
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- AQUACEL AG FOAM 420681Convatec, Purchasing Department · Dressing, Wound, Drug99 reports
- SteriCare Solutions 6240Nurse Assist, Inc. · Dressing, Wound, Drug1 recall14 reports
- MEDLINE MNK0005Medline Industries, Inc. · Dressing, wound, drug1 recall5 reports
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Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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