AQUACEL AG EXTRA 420677Recalls & reported problems

Convatec, Purchasing Department · AQUACEL AG EXTRA 10X12CM(1X10PK)STER NAI · Class U

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

Adverse event reports: 10
Deaths reported: 0
Injuries reported: 0
Recalls naming it: 0

Summary

The FDA's MAUDE database contains 10 adverse event reports that list this exact device (DI 00768455127436), received between Dec 6, 2017 and Dec 6, 2017 — classified as 10 malfunctions.

The most frequently reported specific device problem is “Delivered as Unsterile Product” (10 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.

Most reported problems

Device problems

Delivered as Unsterile Product10
Unsealed Device Packaging10

Patient problems

No Patient Involvement10

Recent adverse event reports

The 10 most recent of 10 reports, in the reporter's own words as published by the FDA.

MalfunctionDec 6, 2017Delivered as Unsterile Product; Unsealed Device Packaging; Delivered as Unsterile Product; Unsealed Device Packaging
THE END USER REPORTED THAT EACH PACKAGE OPENED TOO EASILY AND THERE WERE INTERMITTENT OPEN AREAS ALONG THE SEAL. THE DRESSINGS WERE NOT USED. NO PHOTOGRAPHS OF THE REPORTED ISSUE WERE PROVIDED.
Patient problems: No Patient Involvement
MAUDE report 7088825 ↗
MalfunctionDec 6, 2017Delivered as Unsterile Product; Unsealed Device Packaging; Delivered as Unsterile Product; Unsealed Device Packaging
THE END USER REPORTED THAT EACH PACKAGE OPENED TOO EASILY AND THERE WERE INTERMITTENT OPEN AREAS ALONG THE SEAL. THE DRESSINGS WERE NOT USED. NO PHOTOGRAPHS OF THE REPORTED ISSUE WERE PROVIDED.
Patient problems: No Patient Involvement
MAUDE report 7088824 ↗
MalfunctionDec 6, 2017Delivered as Unsterile Product; Unsealed Device Packaging; Delivered as Unsterile Product; Unsealed Device Packaging
THE END USER REPORTED THAT EACH PACKAGE OPENED TOO EASILY AND THERE WERE INTERMITTENT OPEN AREAS ALONG THE SEAL. THE DRESSINGS WERE NOT USED. NO PHOTOGRAPHS OF THE REPORTED ISSUE WERE PROVIDED.
Patient problems: No Patient Involvement
MAUDE report 7088755 ↗
MalfunctionDec 6, 2017Delivered as Unsterile Product; Unsealed Device Packaging; Delivered as Unsterile Product; Unsealed Device Packaging
THE END USER REPORTED THAT EACH PACKAGE OPENED TOO EASILY AND THERE WERE INTERMITTENT OPEN AREAS ALONG THE SEAL. THE DRESSINGS WERE NOT USED. NO PHOTOGRAPHS OF THE REPORTED ISSUE WERE PROVIDED.
Patient problems: No Patient Involvement
MAUDE report 7088672 ↗
MalfunctionDec 6, 2017Delivered as Unsterile Product; Unsealed Device Packaging; Delivered as Unsterile Product; Unsealed Device Packaging
THE END USER REPORTED THAT EACH PACKAGE OPENED TOO EASILY AND THERE WERE INTERMITTENT OPEN AREAS ALONG THE SEAL. THE DRESSINGS WERE NOT USED. NO PHOTOGRAPHS OF THE REPORTED ISSUE WERE PROVIDED.
Patient problems: No Patient Involvement
MAUDE report 7088608 ↗
MalfunctionDec 6, 2017Delivered as Unsterile Product; Unsealed Device Packaging; Delivered as Unsterile Product; Unsealed Device Packaging
THE END USER REPORTED THAT EACH PACKAGE OPENED TOO EASILY AND THERE WERE INTERMITTENT OPEN AREAS ALONG THE SEAL. THE DRESSINGS WERE NOT USED. NO PHOTOGRAPHS OF THE REPORTED ISSUE WERE PROVIDED.
Patient problems: No Patient Involvement
MAUDE report 7088604 ↗
MalfunctionDec 6, 2017Delivered as Unsterile Product; Unsealed Device Packaging; Delivered as Unsterile Product; Unsealed Device Packaging
THE END USER REPORTED THAT EACH PACKAGE OPENED TOO EASILY AND THERE WERE INTERMITTENT OPEN AREAS ALONG THE SEAL. THE DRESSINGS WERE NOT USED. NO PHOTOGRAPHS OF THE REPORTED ISSUE WERE PROVIDED.
Patient problems: No Patient Involvement
MAUDE report 7088526 ↗
MalfunctionDec 6, 2017Delivered as Unsterile Product; Unsealed Device Packaging; Delivered as Unsterile Product; Unsealed Device Packaging
THE END USER REPORTED THAT EACH PACKAGE OPENED TOO EASILY AND THERE WERE INTERMITTENT OPEN AREAS ALONG THE SEAL. THE DRESSINGS WERE NOT USED. NO PHOTOGRAPHS OF THE REPORTED ISSUE WERE PROVIDED.
Patient problems: No Patient Involvement
MAUDE report 7088358 ↗
MalfunctionDec 6, 2017Delivered as Unsterile Product; Unsealed Device Packaging; Delivered as Unsterile Product; Unsealed Device Packaging
THE END USER REPORTED THAT EACH PACKAGE OPENED TOO EASILY AND THERE WERE INTERMITTENT OPEN AREAS ALONG THE SEAL. THE DRESSINGS WERE NOT USED. NO PHOTOGRAPHS OF THE REPORTED ISSUE WERE PROVIDED.
Patient problems: No Patient Involvement
MAUDE report 7088311 ↗
MalfunctionDec 6, 2017Delivered as Unsterile Product; Unsealed Device Packaging; Delivered as Unsterile Product; Unsealed Device Packaging
THE END USER REPORTED THAT EACH PACKAGE OPENED TOO EASILY AND THERE WERE INTERMITTENT OPEN AREAS ALONG THE SEAL. THE DRESSINGS WERE NOT USED. NO PHOTOGRAPHS OF THE REPORTED ISSUE WERE PROVIDED.
Patient problems: No Patient Involvement
MAUDE report 7088217 ↗

Device details

UDI-DI	`00768455127436`
Brand	AQUACEL AG EXTRA
Model	420677
Company	Convatec, Purchasing Department
Product code	FRO · Dressing, Wound, Drug
Class	Class U
FDA submission	K121275
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	May 23, 2022

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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