AQUACEL AG EXTRA 420675Recalls & reported problems

Convatec, Purchasing Department · AQUACEL AG EXTRA 5X5CM(1X10PK) STER NAI · Class U

Data updated Oct 16, 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 00768455127375), received between Feb 7, 2017 and Feb 7, 2017 — classified as 1 malfunction.

The most frequently reported specific device problem is “Device Operates Differently Than Expected” (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 16, 2026.

Most reported problems

Device problems

Device Operates Differently Than Expected1
Material Disintegration1

Patient problems

No Consequences Or Impact To Patient1

Recent adverse event reports

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

MalfunctionFeb 7, 2017Material Disintegration; Device Operates Differently Than Expected; Material Disintegration; Device Operates Differently Than Expected
IT WAS REPORTED BY A NURSE THAT THE DRESSING DISINTEGRATED AFTER SEVEN DAYS OF USE ON THE PATIENTS RIGHT LEG/FOOT AREA. PHOTOS WERE INCLUDED. NO FURTHER DETAILS HAVE BEEN PROVIDED.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 6308849 ↗

Device details

UDI-DI	`00768455127375`
Brand	AQUACEL AG EXTRA
Model	420675
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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