PremierPro TSAHigh Viscosity Topical Skin Adhesive w/ Mesh 22cm 3472Recalls & reported problems

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

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

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00818566019851), received between Jan 11, 2021 and Mar 14, 2024 — classified as 2 injuries.

The most frequently reported specific device problem is “Insufficient Device Problem Information” (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 18, 2026.

Reports received per month

Last 36 months. The most recent month may be incomplete.

Most reported problems

Device problems

Insufficient Device Problem Information1
Lack of Effect1

Patient problems

Skin Inflammation/ Irritation1
Wound Dehiscence1

Recent adverse event reports

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

InjuryMar 14, 2024Lack of Effect; Lack of Effect
DURING THE POST-OP FOLLOW-UP IN THE CLINIC, TWO WEEKS AFTER SURGERY, EXOFIN FUSION PEELED OFF IN LESS THAN A WEEK. THE PATIENT HAD TO BE SEEN IN THE URGENT CARE FOR WOUND CARE.
Patient problems: Wound Dehiscence
MAUDE report 18906108 ↗
InjuryJan 11, 2021Insufficient Device Problem Information; Insufficient Device Problem Information
THE USER REPORTED THAT THREE PATIENTS EXPERIENCED SKIN REACTIONS AFTER APPLICATION OF EXOFIN FUSION.
Patient problems: Skin Inflammation/ Irritation
MAUDE report 11148299 ↗

Device details

UDI-DI	`00818566019851`
Brand	PremierPro TSAHigh Viscosity Topical Skin Adhesive w/ Mesh 22cm
Model	3472
Company	Prestige Ameritech, Ltd.
Product code	MPN · Tissue Adhesive For The Topical Approximation Of Skin
Class	Class 2
FDA submission	None listed
Implant	No
Rx / OTC	Prescription
Single use	Yes
Sterile	Yes
MRI safety	Labeling does not contain MRI Safety Information
Status	In Commercial Distribution
Record updated	Mar 23, 2026

Device type (GMDN): Dermal surgical adhesive/sealant applicator

A sterile applicator designed to distribute surgical adhesive/sealant for topical application to the skin for various haemostatic and/or tissue bonding uses during a surgical procedure, or as treatment for traumatic or atraumatic cutaneous wounds. It typically consists of a small plastic spout with a brush tip that is attached to a vial of adhesive which is manually squeezed. This is a single-use device.

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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