AQUACEL AG 420670Recalls & reported problems

Convatec, Purchasing Department · AQUACEL AG SCD DRS 9X30CM (1X10PK) NAI · Class U

All models of AQUACEL AG+ (9)

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

Adverse event reports: 1
Deaths reported: 0
Injuries reported: 0
Recalls naming it: 0

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00768455125104), received between Oct 5, 2017 and Oct 5, 2017 — classified as 1 malfunction.

The most frequently reported specific device problem is “Delivered as Unsterile Product” (1 report).

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 Product1
Device Contamination with Chemical or Other Material1

Patient problems

No Patient Involvement1

Recent adverse event reports

The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

MalfunctionOct 5, 2017Delivered as Unsterile Product; Device Contamination with Chemical or Other Material; Delivered as Unsterile Product; Device Contamination with Chemical or Other Material
IT WAS REPORTED THAT A HAIR WAS PRESENT BETWEEN THE ADHESIVE AND THE BACKING. PHOTOS DEPICTING THE REPORTED COMPLAINT ISSUE WERE PROVIDED BY THE COMPLAINANT.
Patient problems: No Patient Involvement
MAUDE report 6918504 ↗

Device details

UDI-DI	`00768455125104`
Brand	AQUACEL AG
Model	420670
Company	Convatec, Purchasing Department
Product code	FRO · Dressing, Wound, Drug
Class	Class U
FDA submission	K091034
Implant	No
Rx / OTC	Prescription
Single use	Yes
Sterile	Yes
MRI safety	Labeling does not contain MRI Safety Information
Status	Not in Commercial Distribution
Record updated	Dec 4, 2023

Device type (GMDN): Exudate-absorbent dressing, hydrophilic-gel, 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, and that contains an antimicrobial agent [e.g., silver (Ag), honey]. It 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 while reducing microbial colonization within the dressing. The device may be in the form of a flat sheet/film, ribbon, rope, foam, liquid, or powder. After application, this device cannot be reused.

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All Dressing, Wound, Drug 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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