AQUACEL FOAM 420637Recalls & reported problems
Convatec, Purchasing Department · AQUACEL FOAM N/ADH 15X20(1X5) NAI · Class 1
All models of AQUACEL FOAM (12)
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 00768455123865), received between Jul 21, 2023 and Dec 29, 2023 — 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.
Reports received per month
Most reported problems
Device problems
- Delivered as Unsterile Product3
- Contamination /Decontamination Problem2
- Packaging Problem1
- Tear, Rip or Hole in Device Packaging1
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.
MalfunctionDec 29, 2023Delivered as Unsterile Product; Contamination /Decontamination Problem; Delivered as Unsterile Product; Contamination /Decontamination Problem
IT WAS REPORTED THAT THERE WAS FOREIGN MATTER (DIRT) FOUND ON DRESSING IN TWO PACKETS. THE PRODUCT WAS NOT USED ON PATIENT. PHOTOGRAPHS DEPICTING THE ISSUE WERE RECEIVED FROM THE COMPLAINANT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18417245 ↗MalfunctionDec 29, 2023Delivered as Unsterile Product; Contamination /Decontamination Problem; Delivered as Unsterile Product; Contamination /Decontamination Problem
TO DATE, ADDITIONAL PATIENT OR EVENT DETAILS WERE RECEIVED WHICH HAVE BEEN ADDED IN H10 (ADDL MFG NARRATIVE).
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18417242 ↗MalfunctionJul 21, 2023Delivered as Unsterile Product; Tear, Rip or Hole in Device Packaging; Packaging Problem; Delivered as Unsterile Product; Tear, Rip or Hole in Device Packaging; Packaging Problem
IT WAS REPORTED BY END USER TO RETAILER THAT THE PRIMARY PACKAGE WAS DAMAGED. 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 17369439 ↗
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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