AQUACEL FOAM 420621Recalls & reported problems

Convatec, Purchasing Department · AQUACEL FOAM ADH 17.5X17.5(1x10) 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 00768455123728), received between Sep 1, 2022 and Feb 20, 2026 — 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 Problem3
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.

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 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 ↗
MalfunctionSep 1, 2022Delivered as Unsterile Product; Unsealed Device Packaging; Packaging Problem; Delivered as Unsterile Product; Unsealed Device Packaging; Packaging Problem
IT WAS REPORTED THAT THE PRODUCT WAS CUT AND CAUGHT IN SEAL. USAGE OF DEVICE WAS UNKNOWN. THE PHOTOGRAPHS DEPICTING THE ISSUE WERE RECEIVED FROM COMPLAINANT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15333939 ↗

Device details

UDI-DI	`00768455123728`
Brand	AQUACEL FOAM
Model	420621
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.

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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.

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