ALGISITE M 4X4" CTN 10 59480200Recalls & reported problems

Smith & Nephew Medical Limited · Calcium Alginate Wound Dressing · Class 1

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

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

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 05000223425104), received between Oct 4, 2021 and Oct 4, 2021 — classified as 1 injury.

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

Adverse Event Without Identified Device or Use Problem1

Patient problems

Skin Inflammation/ Irritation1

Recent adverse event reports

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

InjuryOct 4, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT, DURING A BEDSORE TREATMENT USING A ALGISITE M 10X10CM CTN 10 DRESSING, THE PATIENT EXPERIENCED THE FORMATION OF A SMALL RED PAPULE. THE SYMPTOMS DISAPPEARED AFTER THE ADMINISTRATION OF LORATADINE, IT IS UNKNOWN WHETHER IT CAUSED OR NOT A DELAY IN THE TREATMENT.
Patient problems: Skin Inflammation/ Irritation
MAUDE report 12573810 ↗

Device details

UDI-DI	`05000223425104`
Brand	ALGISITE M 4X4" CTN 10
Model	59480200
Company	Smith & Nephew Medical Limited
Product code	NAC · Dressing, Wound, Hydrophilic
Class	Class 1
FDA submission	None listed
Implant	No
Rx / OTC	OTC
Single use	Yes
Sterile	Yes
MRI safety	Labeling does not contain MRI Safety Information
Status	In Commercial Distribution
Record updated	Sep 7, 2023

Device type (GMDN): Exudate-absorbent dressing, hydrophilic-gel, non-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; it does not contain an antimicrobial agent. The device 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. The device may be in the form of a flat sheet/film, ribbon, rope, foam, liquid, paste, or powder. After application, this device cannot be reused.

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All Dressing, Wound, Hydrophilic 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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