AQUACEL AG 412010Recalls & reported problems

Convatec, Purchasing Department · AQUACEL AG SCD DRS 9X15CM (1X10PK) US · Class U

All models of AQUACEL AG+ (9)

Data updated Oct 16, 2026 from official FDA records · Editorial policy

Adverse event reports: 6
Deaths reported: 0
Injuries reported: 0
Recalls naming it: 0

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 00768455124282), received between Mar 13, 2025 and Mar 27, 2025 — classified as 6 malfunctions.

The most frequently reported specific device problem is “Delivered as Unsterile Product” (6 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 16, 2026.

Reports received per month

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

Most reported problems

Device problems

Delivered as Unsterile Product6
Device Damaged Prior to Use5
Unsealed Device Packaging5
Contamination /Decontamination Problem1

Patient problems

No Clinical Signs, Symptoms or Conditions6

Recent adverse event reports

The 6 most recent of 6 reports, in the reporter's own words as published by the FDA.

MalfunctionMar 27, 2025Delivered as Unsterile Product; Unsealed Device Packaging; Device Damaged Prior to Use; Delivered as Unsterile Product; Unsealed Device Packaging; Device Damaged Prior to Use
THE DISTRIBUTOR REPORTED THAT, THE DRESSING PACKAGE WAS UNSTITCHED/SHREDDED AND WAS FOUND DURING UNDRESSING. THE PRODUCT WAS NOT USED. PHOTOGRAPHS DEPICTING THE ISSUE WERE RECEIVED FROM THE COMPLAINANT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21705828 ↗
MalfunctionMar 27, 2025Delivered as Unsterile Product; Unsealed Device Packaging; Device Damaged Prior to Use; Delivered as Unsterile Product; Unsealed Device Packaging; Device Damaged Prior to Use
THE DISTRIBUTOR REPORTED THAT, THE DRESSING PACKAGE WAS UNSTITCHED/SHREDDED AND WAS FOUND DURING UNDRESSING. THE PRODUCT WAS NOT USED. PHOTOGRAPHS DEPICTING THE ISSUE WERE RECEIVED FROM THE COMPLAINANT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21705826 ↗
MalfunctionMar 27, 2025Delivered as Unsterile Product; Unsealed Device Packaging; Device Damaged Prior to Use; Delivered as Unsterile Product; Unsealed Device Packaging; Device Damaged Prior to Use
THE DISTRIBUTOR REPORTED THAT, THE DRESSING PACKAGE WAS UNSTITCHED/SHREDDED AND WAS FOUND DURING UNDRESSING. THE PRODUCT WAS NOT USED. PHOTOGRAPHS DEPICTING THE ISSUE WERE RECEIVED FROM THE COMPLAINANT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21705824 ↗
MalfunctionMar 27, 2025Delivered as Unsterile Product; Unsealed Device Packaging; Device Damaged Prior to Use; Delivered as Unsterile Product; Unsealed Device Packaging; Device Damaged Prior to Use
THE DISTRIBUTOR REPORTED THAT, THE DRESSING PACKAGE WAS UNSTITCHED/SHREDDED AND WAS FOUND DURING UNDRESSING. THE PRODUCT WAS NOT USED. PHOTOGRAPHS DEPICTING THE ISSUE WERE RECEIVED FROM THE COMPLAINANT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21705823 ↗
MalfunctionMar 27, 2025Delivered as Unsterile Product; Unsealed Device Packaging; Device Damaged Prior to Use; Delivered as Unsterile Product; Unsealed Device Packaging; Device Damaged Prior to Use
THE DISTRIBUTOR REPORTED THAT, THE DRESSING PACKAGE WAS UNSTITCHED/SHREDDED AND WAS FOUND DURING UNDRESSING. THE PRODUCT WAS NOT USED. PHOTOGRAPHS DEPICTING THE ISSUE WERE RECEIVED FROM THE COMPLAINANT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21705822 ↗
MalfunctionMar 13, 2025Delivered as Unsterile Product; Contamination /Decontamination Problem; Delivered as Unsterile Product; Contamination /Decontamination Problem
THE HOSPITAL NOTIFIED THE DISTRIBUTOR THAT THE DRESSING HAD TURNED AN ABNORMAL BLACK COLOR. UPON OPENING A BRAND-NEW PRODUCT, IT WAS OBSERVED THAT THE COLOR WAS DIFFERENT FROM WHAT WAS EXPECTED. THE PRODUCT WAS NOT USED BY THE PATIENT. THE PHOTOGRAPHS DEPICTING THE ISSUE WERE RECEIVED FROM THE COMPLAINANT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21591517 ↗

Device details

UDI-DI	`00768455124282`
Brand	AQUACEL AG
Model	412010
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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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 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.

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