TRIAD 1967Recalls & reported problems

Coloplast A/S · Hydrophilic paste · Class 1

Data updated Oct 16, 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 00311701031324), received between Apr 26, 2018 and Apr 26, 2018 — classified as 1 injury.

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

Patient problems

Impaired Healing1

Recent adverse event reports

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

InjuryApr 26, 2018Device Operates Differently Than Expected
PATIENT WITH DIABETIC FOOT ULCER TRIED THE PRODUCT FOR 3-4 DAYS AND IT DIDN'T HEAL THE WOUND. USED ANOTHER PRODUCT INITIALLY- REGRANEX. REFER TO MEDWATCH (B)(4) FOR ADDITIONAL DETAILS.
Patient problems: Impaired Healing
MAUDE report 7465772 ↗

Device details

UDI-DI	`00311701031324`
Brand	TRIAD
Model	1967
Company	Coloplast A/S
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	Jan 17, 2024

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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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 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.

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