AQUACEL FOAM 420635Recalls & reported problems

Convatec, Purchasing Department · AQUACEL FOAM N/ADH 15X15(1X5) NAI · Class 1

All models of AQUACEL FOAM (12)

Data updated Oct 18, 2026 from official FDA records · Editorial policy

Adverse event reports: 4
Deaths reported: 0
Injuries reported: 0
Recalls naming it: 0

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 00768455123841), received between Oct 12, 2022 and Mar 7, 2025 — classified as 4 malfunctions.

The most frequently reported specific device problem is “Delivered as Unsterile Product” (4 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

Last 36 months. The most recent month may be incomplete.

Most reported problems

Device problems

Delivered as Unsterile Product4
Contamination /Decontamination Problem2
Device Damaged Prior to Use2
Device Contaminated During Manufacture or Shipping1
Packaging Problem1
Unsealed Device Packaging1

Patient problems

No Clinical Signs, Symptoms or Conditions4

Recent adverse event reports

The 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

MalfunctionMar 7, 2025Delivered as Unsterile Product; Device Damaged Prior to Use; Packaging Problem; Delivered as Unsterile Product; Device Damaged Prior to Use; Packaging Problem
TO DATE NO ADDITIONAL PATIENT OR EVENT DETAILS HAVE BEEN RECEIVED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21544122 ↗
MalfunctionJul 5, 2024Delivered as Unsterile Product; Unsealed Device Packaging; Device Damaged Prior to Use; Delivered as Unsterile Product; Unsealed Device Packaging; Device Damaged Prior to Use
IT WAS REPORTED BY DISTRIBUTOR THAT THERE WAS DAMAGE TO PACKAGING AND SEAL WAS INCOMPLETE. 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 19677721 ↗
MalfunctionNov 14, 2023Delivered as Unsterile Product; Contamination /Decontamination Problem; Delivered as Unsterile Product; Contamination /Decontamination Problem
IT WAS REPORTED BY THE RETAILER THAT THERE WAS STAIN (RED MARKS) ON DRESSING. THE PRODUCT WAS NOT USED ON PATIENT. A PHOTOGRAPH DEPICTING THE ISSUE WAS RECEIVED FROM THE COMPLAINANT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18130045 ↗
MalfunctionOct 12, 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 HAIRS WERE FOUND INSIDE THE PRIMARY PACKAGING. 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 15585667 ↗

Device details

UDI-DI	`00768455123841`
Brand	AQUACEL FOAM
Model	420635
Company	Convatec, Purchasing Department
Product code	NAC · Dressing, Wound, Hydrophilic
Class	Class 1
FDA submission	None listed
Implant	No
Rx / OTC	OTC
Single use	Yes
Sterile	Yes
MRI safety	Labeling does not contain MRI Safety Information
Status	In Commercial Distribution
Record updated	Aug 9, 2023

Device type (GMDN): Exudate-absorbent dressing, hydrophilic-gel, non-antimicrobial

A wound covering, typically made of a hydrocolloid, hydrofibre, chitosan or alginate (salts and acids extracted from seaweed), intended to produce a water-absorbent gel upon contact with wound exudate; it does not contain an antimicrobial agent. The device assists in wound healing by absorbing exudate in wounds (e.g., ulcers, burns, surgical wounds, lacerations, abrasions) for minimal wound maceration, allowing wound debridement, and creating a moist wound-healing environment. The device may be in the form of a flat sheet/film, ribbon, rope, foam, liquid, paste, or powder. After application, this device cannot be reused.

Other Dressing, Wound, Hydrophilic devices

MEDLINE INDUSTRIES, INC. MSC7044EP
Medline Industries, Inc. · Dressing, wound, hydrophilic
1 recall1 report
McKesson Reinforced Alginate
Advanced Medical Solutions Limited · Dressing, Wound, Hydrophilic
1 recall0 reports
McKesson 3561
Mckesson Medical-Surgical Inc. · Dressing, Wound, Hydrophilic
1 recall0 reports
McKesson 3563
Mckesson Medical-Surgical Inc. · Dressing, Wound, Hydrophilic
1 recall0 reports
McKesson 87400
Mckesson Medical-Surgical Inc. · Dressing, Wound, Hydrophilic
1 recall0 reports
DuPad® 87810
Derma Sciences Canada Inc · Dressing, wound, hydrophilic
1 recall0 reports
MAXORB EXTRA Alginate
Medline Industries, Inc. · Dressing, Wound, Hydrophilic
1 recall0 reports
McKesson 3562
Mckesson Medical-Surgical Inc. · Dressing, Wound, Hydrophilic
1 recall0 reports

All Dressing, Wound, Hydrophilic devices →

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.

How reports and recalls are matched · Editorial policy · Report an error on this page