AQUACEL AG EXTRA 420678Recalls & reported problems
Convatec, Purchasing Department · AQUACEL AG EXTRA 15X15CM(1X5PK) 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
- 1
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00768455127450), received between Aug 22, 2017 and Aug 22, 2017 — classified as 1 injury.
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
- Adverse Event Without Identified Device or Use Problem1
Patient problems
- Cellulitis1
- Discharge1
- Skin Discoloration1
- Tissue Damage1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjuryAug 22, 2017Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT THE END USER STARTED USING AQUACEL AG EXTRA TO THE RIGHT AND LEFT ISCHIUM PRESSURE ULCERS SOMETIME IN (B)(6) 2017. THE DRESSING WAS CHANGED DAILY BY HER HUSBAND OR HOME HEALTH NURSE. THE PERI-WOUND SKIN WAS CLEANED WITH MEDLINE SKINTEGRITY WOUND CLEANSER. AQUACEL AG EXTRA WAS APPLIED, THEN COVERED WITH GAUZE AND SECURED WITH SELF-ADHESIVE ROLL DRESSING. END USER DEVELOPED CELLULITIS (I.E., RED, WEEPY, EDEMATOUS SKIN) SURROUNDING THE WOUNDS WHICH THEN SPREAD TO ENTIRE BODY UP TO HER MOUTH. IT WAS REPORTED THAT THE END USER EXPERIENCED FROTHING AT THE MOUTH AT THIS TIME AND THE WOUND BED DEVELOPED ESCHAR. A WOUND CULTURE WAS TAKEN AND END USER WAS STARTED ON PRESCRIPTION BACTRIM. THE END USER FEELS THE CELLULITIS AND OTHER SYMPTOMS ARE A RESULT OF AN ALLERGIC REACTION TO THE AQUACEL AG EXTRA HOWEVER IT IS NOT KNOWN IF THE DOCTOR PROVIDED THE SAME DIAGNOSIS. IT WAS ALSO REPORTED THAT THE END USER AT FIRST DID NOT THINK THE PRODUCT WAS THE CAUSE OF THE ALLERGIC REACTION BUT AT THE BEGINNING OF (B)(6) 2017 THE AQUACEL AG EXTRA WAS DISCONTINUED. IT WAS NOTED THAT THE END USER RETURNED TO USING THE PREVIOUS DRESSING DAKINS SOLUTION AND THE ISSUE WAS RESOLVED COMPLETEL
Patient problems: Cellulitis; Discharge; Skin Discoloration; Tissue Damage
MAUDE report 6809906 ↗
Other Dressing, Wound, Drug devices
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- MediHoney® 31515Acell, Inc. · Dressing, wound, drug2 recalls6 reports
- MediHoney® 31805Acell, Inc. · Dressing, wound, drug2 recalls1 death5 reports
- 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
- Medline DYND500MLSMedline Industries, Inc. · Dressing, wound, drug1 recall5 reports
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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