AQUACEL FOAM PRO 422359Recalls & reported problems
Convatec, Purchasing Department · Aquacel® Foam Pro 3x3" · Class 1
All models of AQUACEL FOAM PRO (6)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 3
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00768455157341), received between Mar 10, 2022 and Oct 21, 2022 — classified as 3 malfunctions.
The most frequently reported specific device problem is “Delivered as Unsterile Product” (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.
Most reported problems
Device problems
- Delivered as Unsterile Product3
- Unsealed Device Packaging2
- Contamination /Decontamination Problem1
- Device Contaminated During Manufacture or Shipping1
Patient problems
- No Clinical Signs, Symptoms or Conditions3
Recent adverse event reports
The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.
MalfunctionOct 21, 2022Delivered as Unsterile Product; Contamination /Decontamination Problem; Device Contaminated During Manufacture or Shipping; Delivered as Unsterile Product; Contamination /Decontamination Problem; Device Contaminated During Manufacture or Shipping
IT WAS REPORTED THAT THERE WAS VISIBLE HAIR IN SEALED SACHET. THE PRODUCT WAS NOT USED BY PATIENT. THE PHOTOGRAPHS DEPICTING THE ISSUE WERE RECEIVED FROM THE COMPLAINANT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15646075 ↗MalfunctionMar 10, 2022Delivered as Unsterile Product; Unsealed Device Packaging; Delivered as Unsterile Product; Unsealed Device Packaging
BASED ON THE PICTURES RECEIVED FROM THE COMPLAINANT, THERE WERE UNSEALED PACKAGES. THE PRODUCT WAS NOT USED ON PATIENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 13718852 ↗MalfunctionMar 10, 2022Delivered as Unsterile Product; Unsealed Device Packaging; Delivered as Unsterile Product; Unsealed Device Packaging
BASED ON THE PICTURES RECEIVED FROM THE COMPLAINANT, THERE WERE UNSEALED PACKAGES. THE PRODUCT WAS NOT USED ON PATIENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 13718843 ↗
Other Dressing, Wound, Hydrophilic devices
- MEDLINE INDUSTRIES, INC. MSC7044EPMedline Industries, Inc. · Dressing, wound, hydrophilic1 recall1 report
- McKesson Reinforced AlginateAdvanced Medical Solutions Limited · Dressing, Wound, Hydrophilic1 recall0 reports
- McKesson 3561Mckesson Medical-Surgical Inc. · Dressing, Wound, Hydrophilic1 recall0 reports
- McKesson 3563Mckesson Medical-Surgical Inc. · Dressing, Wound, Hydrophilic1 recall0 reports
- McKesson 87400Mckesson Medical-Surgical Inc. · Dressing, Wound, Hydrophilic1 recall0 reports
- DuPad® 87810Derma Sciences Canada Inc · Dressing, wound, hydrophilic1 recall0 reports
- MAXORB EXTRA AlginateMedline Industries, Inc. · Dressing, Wound, Hydrophilic1 recall0 reports
- McKesson 3562Mckesson Medical-Surgical Inc. · Dressing, Wound, Hydrophilic1 recall0 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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