AQUACEL FOAMRecalls & reported problems across all models
Convatec, Purchasing Department · 12 models in the FDA device registry
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 108
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls
- 0
We found 12 models of AQUACEL FOAM by Convatec, Purchasing Department in the FDA's device registry (GUDID). Together they are named in 108 adverse event reports in the FDA's MAUDE database, received between Dec 3, 2021 and Aug 6, 2026 — classified as 1 injury, 107 malfunctions.
The most frequently reported specific device problem is “Delivered as Unsterile Product” (92 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. Widely used products collect more reports, so totals can't be used to compare products or estimate failure rates. Only reports that name a model's exact device identifier are counted. What reports can and can't tell you · How this data works
Reports received per month, all models
Most reported AQUACEL FOAM problems
Device problems
- Delivered as Unsterile Product92
- Contamination /Decontamination Problem85
- Difficult to Remove12
- Packaging Problem5
- Unsealed Device Packaging5
- Device Damaged Prior to Use3
- Patient-Device Incompatibility3
- Device Contaminated During Manufacture or Shipping2
Patient problems
- No Clinical Signs, Symptoms or Conditions103
- Tissue Breakdown5
- Erythema1
AQUACEL FOAM models
12 models, most reported first. Each model has its own page with its reports, recalls and device details.
- AQUACEL FOAM 420804Dressing, Wound, Hydrophilic26 reports
- AQUACEL FOAM 420633Dressing, Wound, Hydrophilic25 reports
- AQUACEL FOAM 420680Dressing, Wound, Hydrophilic15 reports
- AQUACEL FOAM 421561Dressing, wound, occlusive10 reports
- AQUACEL FOAM 421557Dressing, Wound, Hydrophilic7 reports
- AQUACEL FOAM 420619Dressing, Wound, Hydrophilic6 reports
- AQUACEL FOAM 421927Dressing, Wound, Hydrophilic5 reports
- AQUACEL FOAM 420621Dressing, Wound, Hydrophilic4 reports
- AQUACEL FOAM 420635Dressing, Wound, Hydrophilic4 reports
- AQUACEL FOAM 420637Dressing, Wound, Hydrophilic3 reports
- AQUACEL FOAM 421559Dressing, Wound, Hydrophilic2 reports
- AQUACEL FOAM 421151Dressing, Wound, Hydrophilic1 report
Recent AQUACEL FOAM adverse event reports
The 15 most recent reports across all models, in the reporter's own words as published by the FDA.
MalfunctionAug 6, 2026Delivered as Unsterile Product; Unsealed Device Packaging; Device Damaged Prior to Receipt by User
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50158207 ↗MalfunctionFeb 20, 2026Delivered as Unsterile Product; Contamination /Decontamination Problem
THE DISTRIBUTOR REPORTED THAT DURING INBOUND INSPECTION FOREIGN BODY WAS FOUND WITHIN PRODUCT. THE PRODUCT WAS NOT USED. A PHOTOGRAPH DEPICTING THE ISSUE WAS RECEIVED FROM THE COMPLAINANT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24399205 ↗MalfunctionFeb 20, 2026Delivered as Unsterile Product; Contamination /Decontamination Problem
THE DISTRIBUTOR REPORTED THAT DURING INBOUND INSPECTION FOREIGN BODY WAS FOUND WITHIN PRODUCT. THE PRODUCT WAS NOT USED. A PHOTOGRAPH DEPICTING THE ISSUE WAS RECEIVED FROM THE COMPLAINANT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24399201 ↗MalfunctionFeb 20, 2026Delivered as Unsterile Product; Contamination /Decontamination Problem
THE DISTRIBUTOR REPORTED THAT DURING INBOUND INSPECTION FOREIGN BODY WAS FOUND WITHIN PRODUCT. THE PRODUCT WAS NOT USED. A PHOTOGRAPH DEPICTING THE ISSUE WAS RECEIVED FROM THE COMPLAINANT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24399199 ↗MalfunctionFeb 20, 2026Delivered as Unsterile Product; Contamination /Decontamination Problem
THE DISTRIBUTOR REPORTED THAT DURING INBOUND INSPECTION FOREIGN BODY WAS FOUND WITHIN PRODUCT. THE PRODUCT WAS NOT USED. A PHOTOGRAPH DEPICTING THE ISSUE WAS RECEIVED FROM THE COMPLAINANT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24399198 ↗MalfunctionFeb 20, 2026Delivered as Unsterile Product; Contamination /Decontamination Problem
THE DISTRIBUTOR REPORTED THAT DURING INBOUND INSPECTION FOREIGN BODY WAS FOUND WITHIN PRODUCT. THE PRODUCT WAS NOT USED. A PHOTOGRAPH DEPICTING THE ISSUE WAS RECEIVED FROM THE COMPLAINANT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24399195 ↗MalfunctionFeb 20, 2026Delivered as Unsterile Product; Contamination /Decontamination Problem
THE DISTRIBUTOR REPORTED THAT DURING INBOUND INSPECTION FOREIGN BODY WAS FOUND WITHIN PRODUCT. THE PRODUCT WAS NOT USED. A PHOTOGRAPH DEPICTING THE ISSUE WAS RECEIVED FROM THE COMPLAINANT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24399194 ↗MalfunctionFeb 20, 2026Delivered as Unsterile Product; Contamination /Decontamination Problem
THE DISTRIBUTOR REPORTED THAT DURING INBOUND INSPECTION FOREIGN BODY WAS FOUND WITHIN PRODUCT. THE PRODUCT WAS NOT USED. A PHOTOGRAPH DEPICTING THE ISSUE WAS RECEIVED FROM THE COMPLAINANT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24399193 ↗MalfunctionFeb 20, 2026Delivered as Unsterile Product; Contamination /Decontamination Problem
THE DISTRIBUTOR REPORTED THAT DURING INBOUND INSPECTION SPOTS WITH DIFFERENT COLOR WERE FOUND WITHIN PRODUCT. THE PRODUCT WAS NOT USED. A PHOTOGRAPH DEPICTING THE ISSUE WAS RECEIVED FROM THE COMPLAINANT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24399168 ↗MalfunctionFeb 20, 2026Delivered as Unsterile Product; Contamination /Decontamination Problem
THE DISTRIBUTOR REPORTED THAT DURING INBOUND INSPECTION FOREIGN BODY WAS FOUND WITHIN THE PRIMARY PACK. THE PRODUCT WAS NOT USED. A PHOTOGRAPH DEPICTING THE ISSUE WAS RECEIVED FROM THE COMPLAINANT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24399166 ↗MalfunctionFeb 20, 2026Delivered as Unsterile Product; Contamination /Decontamination Problem
THE DISTRIBUTOR REPORTED THAT DURING INBOUND INSPECTION SPOTS WITH DIFFERENT COLOR WERE FOUND WITHIN PRODUCT. THE PRODUCT WAS NOT USED. A PHOTOGRAPH DEPICTING THE ISSUE WAS RECEIVED FROM THE COMPLAINANT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24399165 ↗MalfunctionFeb 20, 2026Delivered as Unsterile Product; Contamination /Decontamination Problem
THE DISTRIBUTOR REPORTED THAT DURING INBOUND INSPECTION FOREIGN BODY WAS FOUND WITHIN THE PRIMARY PACK. THE PRODUCT WAS NOT USED. A PHOTOGRAPH DEPICTING THE ISSUE WAS RECEIVED FROM THE COMPLAINANT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24399127 ↗MalfunctionFeb 20, 2026Delivered as Unsterile Product; Contamination /Decontamination Problem
THE DISTRIBUTOR REPORTED THAT DURING INBOUND INSPECTION FOREIGN BODY WAS FOUND WITHIN THE PRIMARY PACK. THE PRODUCT WAS NOT USED. A PHOTOGRAPH DEPICTING THE ISSUE WAS RECEIVED FROM THE COMPLAINANT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24399126 ↗MalfunctionJan 16, 2026Delivered as Unsterile Product; Contamination /Decontamination Problem
TO DATE NO ADDITIONAL PATIENT OR EVENT DETAILS HAVE BEEN RECEIVED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24092123 ↗MalfunctionJan 15, 2026Delivered as Unsterile Product; Contamination /Decontamination Problem
TO DATE NO ADDITIONAL PATIENT OR EVENT DETAILS HAVE BEEN RECEIVED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24077842 ↗
Other Convatec, Purchasing Department products
- DUODERM9 models · 7,142 reports · 1 recall
- SUR-FIT NATURA43 models · 6,207 reports · 2 recalls
- NATURA15 models · 5,161 reports
- CURE CATHETER25 models · 862 reports
- GENTLECATH GLIDE9 models · 572 reports
- ESTEEM52 models · 200 reports · 7 recalls
- ACTIVELIFE21 models · 437 reports · 2 recalls
- GENTLECATH8 models · 430 reports
Sources and updates
- Models: FDA GUDID, file dated Oct 13, 2026. Models are grouped by the brand name the manufacturer registered.
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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