AQUACEL AG EXTRA 420676Recalls & reported problems
Convatec, Purchasing Department · AQUACEL AG EXTRA 10X10CM(1X10PK)STER NAI · Class U
All models of AQUACEL AG EXTRA (7)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 2
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00768455127405), received between Oct 3, 2017 and Dec 19, 2017 — classified as 2 malfunctions.
The most frequently reported specific device problem is “Delivered as Unsterile Product” (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
Device problems
- Delivered as Unsterile Product2
- Device Contamination with Chemical or Other Material1
Patient problems
- No Patient Involvement2
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
MalfunctionDec 19, 2017Delivered as Unsterile Product; Delivered as Unsterile Product
IT WAS REPORTED UPON OPENING A 10X10CM AQUACEL AG EXTRA DRESSING, THE DRESSING SEATED IN THE PACKET WAS NOT CORRECTLY ORIENTATED AND AS A RESULT APPEARS TO HAVE BEEN HEAT SEALED IN THE PACKET RENDERING IT UNSTERILE. PHOTOS DEPICTING THE REPORTED COMPLAINT ISSUE WERE PROVIDED BY THE COMPLAINANT.
Patient problems: No Patient Involvement
MAUDE report 7130753 ↗MalfunctionOct 3, 2017Delivered as Unsterile Product; Device Contamination with Chemical or Other Material; Delivered as Unsterile Product; Device Contamination with Chemical or Other Material
IT WAS REPORTED BY A NURSE PRACTITIONER THAT A FOREIGN BODY APPEARING TO BE A SMALL WORM OR INSECT WAS NOTED IN THE AQUACEL AG+ DRESSING WHEN OPENED. THE DRESSING WAS NOT USED ON A PATIENT. A PHOTOGRAPH DEPICTING THE ISSUE WAS PROVIDED. NO FURTHER INFORMATION WAS PROVIDED.
Patient problems: No Patient Involvement
MAUDE report 6911288 ↗
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- MediHoney® 31535Acell, Inc. · Dressing, wound, drug2 recalls0 reports
- 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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