AQUACEL AG+ ADVANTAGE 422301Recalls & reported problems

Convatec, Purchasing Department · Aquacel® Ag Advantage Enhanced Hydrofiber® Dressing With Silver .39X18" (1X45Cm) · Class U

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

Adverse event reports: 2
Deaths reported: 0
Injuries reported: 0
Recalls naming it: 0

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00768455154401), received between Nov 30, 2023 and Nov 30, 2023 — classified as 2 malfunctions.

The most frequently reported specific device problem is “Delivered as Unsterile Product” (2 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 Product2
Device Damaged Prior to Use2
Packaging Problem2
Unsealed Device Packaging2

Patient problems

No Clinical Signs, Symptoms or Conditions2

Recent adverse event reports

The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

MalfunctionNov 30, 2023Delivered as Unsterile Product; Unsealed Device Packaging; Device Damaged Prior to Use; Packaging Problem; Delivered as Unsterile Product; Unsealed Device Packaging; Device Damaged Prior to Use; Packaging Problem
THE END USER REPORTED THAT THE TWO DRESSINGS FROM THE SAME LOT HAD DRESSING PACKAGING COMPROMISED PRIOR TO USE. THE PRODUCT WAS RECEIVED FROM THE RETAILER AND WAS NOT SENT IN THE ORIGINAL MARKET UNIT BOX. INDIVIDUAL DRESSINGS WERE SENT INSIDE A ZIPLOC-STYLED PLASTIC BAG. ONE OF THE DRESSINGS WAS ALREADY OPENED, COMPROMISING THE STERILITY OF THE DRESSING. THE OTHER DRESSING WAS SEALED INTO THE EDGE OF THE PACKAGE, COMPROMISING THE STERILITY OF THE DRESSING AND DAMAGING THE DRESSING. THE PRODUCT WAS NOT USED BY PATIENT. THE PHOTOGRAPHS DEPICTING THE ISSUE WERE RECEIVED FROM THE END USER.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18235359 ↗
MalfunctionNov 30, 2023Delivered as Unsterile Product; Unsealed Device Packaging; Device Damaged Prior to Use; Packaging Problem; Delivered as Unsterile Product; Unsealed Device Packaging; Device Damaged Prior to Use; Packaging Problem
THE END USER REPORTED THAT THE TWO DRESSINGS FROM THE SAME LOT HAD DRESSING PACKAGING COMPROMISED PRIOR TO USE. THE PRODUCT WAS RECEIVED FROM THE RETAILER AND WAS NOT SENT IN THE ORIGINAL MARKET UNIT BOX. INDIVIDUAL DRESSINGS WERE SENT INSIDE A ZIPLOC-STYLED PLASTIC BAG. ONE OF THE DRESSINGS WAS ALREADY OPENED, COMPROMISING THE STERILITY OF THE DRESSING. THE OTHER DRESSING WAS SEALED INTO THE EDGE OF THE PACKAGE, COMPROMISING THE STERILITY OF THE DRESSING AND DAMAGING THE DRESSING. THE PRODUCT WAS NOT USED BY PATIENT. THE PHOTOGRAPHS DEPICTING THE ISSUE WERE RECEIVED FROM THE END USER.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18235358 ↗

Device details

UDI-DI	`00768455154401`
Brand	AQUACEL AG+ ADVANTAGE
Model	422301
Company	Convatec, Purchasing Department
Product code	FRO · Dressing, Wound, Drug
Class	Class U
FDA submission	None listed
Implant	No
Rx / OTC	Prescription
Single use	Yes
Sterile	Yes
MRI safety	MR Safe
Status	In Commercial Distribution
Record updated	Aug 9, 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 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.

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