AQUACEL FOAM 420633Recalls & reported problems
Convatec, Purchasing Department · AQUACEL FOAM N/ADH 10X10(1X10) NAI · Class 1
All models of AQUACEL FOAM (12)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
Quick summary
This Convatec Aquacel Foam wound dressing is a hydrophilic dressing for wounds. Recent reports describe foreign material or discolored spots found inside unused dressings during inspection. There are 25 reports naming its identifier, with no deaths and no injuries. No recalls name this device, with 9 reports in the recent period compared with 2 in the earlier period.
AI-generated from the FDA records on this page and checked automatically against the numbers below. Read the details before relying on it.
- Adverse event reports
- 25
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 25 adverse event reports that list this exact device (DI 00768455123834), received between Aug 10, 2023 and Feb 20, 2026 — classified as 25 malfunctions.
The most frequently reported specific device problem is “Contamination /Decontamination Problem” (25 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
- Contamination /Decontamination Problem25
- Delivered as Unsterile Product25
Patient problems
- No Clinical Signs, Symptoms or Conditions25
Recent adverse event reports
The 25 most recent of 25 reports, in the reporter's own words as published by the FDA.
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 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 ↗MalfunctionOct 17, 2025Delivered as Unsterile Product; Contamination /Decontamination Problem; Delivered as Unsterile Product; Contamination /Decontamination Problem
THE DISTRIBUTOR NOTIFIED REGARDING AN INBOUND INSPECTION. THE INSPECTION IDENTIFIED SPOTS WITH DIFFERENT COLOR ON THE SIX DRESSINGS. THE PRODUCT WAS NOT USED; THEREFORE, NO HARM WAS REPORTED. THE PHOTOGRAPHS DEPICTING THE ISSUE WERE RECEIVED FROM THE COMPLAINANT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23321312 ↗MalfunctionJan 23, 2025Delivered as Unsterile Product; Contamination /Decontamination Problem; Delivered 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 21214922 ↗MalfunctionApr 5, 2024Delivered as Unsterile Product; Contamination /Decontamination Problem; Delivered as Unsterile Product; Contamination /Decontamination Problem
THE DISTRIBUTOR REPORTED THAT BLACK DOTS WERE FOUND ON THE DRESSING. THE PRODUCT WAS NOT USED BY PATIENT. PHOTOGRAPHS DEPICTING THE ISSUE WERE RECEIVED FROM THE COMPLAINANT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19049339 ↗MalfunctionApr 5, 2024Delivered as Unsterile Product; Contamination /Decontamination Problem; Delivered as Unsterile Product; Contamination /Decontamination Problem
IT WAS REPORTED BY THE DISTRIBUTOR THAT THERE WAS A FOREIGN MATTER ON THE DRESSING. THE PRODUCT WAS NOT USED BY PATIENT. PHOTOGRAPHS DEPICTING THE ISSUE WERE RECEIVED FROM THE COMPLAINANT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19049276 ↗MalfunctionApr 5, 2024Delivered as Unsterile Product; Contamination /Decontamination Problem; Delivered as Unsterile Product; Contamination /Decontamination Problem
IT WAS REPORTED BY THE DISTRIBUTOR THAT THERE WAS A BLACK DOT ON THE DRESSING. THE PRODUCT WAS NOT USED BY PATIENT. PHOTOGRAPHS DEPICTING THE ISSUE WERE RECEIVED FROM THE COMPLAINANT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19049228 ↗MalfunctionApr 5, 2024Delivered as Unsterile Product; Contamination /Decontamination Problem; Delivered as Unsterile Product; Contamination /Decontamination Problem
THE DISTRIBUTOR REPORTED THAT THERE WAS A FOREIGN MATTER (CLOTH FIBRE) ON THE DRESSING. THE PRODUCT WAS NOT USED BY THE PATIENT. PHOTOGRAPHS DEPICTING THE ISSUE WERE RECEIVED FROM THE COMPLAINANT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19049036 ↗MalfunctionApr 5, 2024Delivered as Unsterile Product; Contamination /Decontamination Problem; Delivered 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 19049033 ↗MalfunctionApr 5, 2024Delivered as Unsterile Product; Contamination /Decontamination Problem; Delivered 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 19049032 ↗MalfunctionApr 5, 2024Delivered as Unsterile Product; Contamination /Decontamination Problem; Delivered as Unsterile Product; Contamination /Decontamination Problem
THE DISTRIBUTOR REPORTED THAT THERE WAS A FOREIGN MATTER (CLOTH FIBRE) ON THE DRESSING. THE PRODUCT WAS NOT USED BY THE PATIENT. PHOTOGRAPHS DEPICTING THE ISSUE WERE RECEIVED FROM THE COMPLAINANT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19049031 ↗MalfunctionApr 5, 2024Delivered as Unsterile Product; Contamination /Decontamination Problem; Delivered 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 19049030 ↗MalfunctionApr 5, 2024Delivered as Unsterile Product; Contamination /Decontamination Problem; Delivered as Unsterile Product; Contamination /Decontamination Problem
THE DISTRIBUTOR REPORTED THAT THERE WAS A FOREIGN MATTER (CLOTH FIBRE) ON THE DRESSING. THE PRODUCT WAS NOT USED BY THE PATIENT. PHOTOGRAPHS DEPICTING THE ISSUE WERE RECEIVED FROM THE COMPLAINANT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19049029 ↗MalfunctionApr 5, 2024Delivered as Unsterile Product; Contamination /Decontamination Problem; Delivered 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 19049027 ↗MalfunctionApr 5, 2024Delivered as Unsterile Product; Contamination /Decontamination Problem; Delivered 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 19049026 ↗MalfunctionJan 22, 2024Delivered as Unsterile Product; Contamination /Decontamination Problem; Delivered 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 18550654 ↗MalfunctionAug 10, 2023Delivered as Unsterile Product; Contamination /Decontamination Problem; Delivered as Unsterile Product; Contamination /Decontamination Problem
IT WAS REPORTED BY THE RETAILER THAT THE DRESSING WAS DIRTY WITH SMUDGED PRINT AND RED DOT. THE PRODUCT WAS NOT USED BY PATIENT. THE PHOTOGRAPHS DEPICTING THE ISSUE WERE RECEIVED FROM THE END USER.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17499770 ↗MalfunctionAug 10, 2023Delivered as Unsterile Product; Contamination /Decontamination Problem; Delivered 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 17499768 ↗
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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