exofin MICRO HVTSA, 0.5g EX71010Recalls & reported problems

Chemence Medical, Inc. · Micro HVTSA, 0.5g and HVTSA SourceMark Product code M1206 and M1206-01 · Class 2

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

Adverse event reports: 2
Deaths reported: 0
Injuries reported: 1
Recalls naming it: 0

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00854137001153), received between Aug 24, 2020 and Apr 13, 2026 — classified as 1 injury, 1 malfunction.

The most frequently reported specific device problem is “Detachment of Device or Device Component” (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

Detachment of Device or Device Component1
Insufficient Device Problem Information1

Patient problems

Contact Dermatitis1
Itching Sensation1
No Consequences Or Impact To Patient1
Skin Burning Sensation1

Recent adverse event reports

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

InjuryApr 13, 2026Insufficient Device Problem Information
THE COMPLAINANT REPORTED THAT MULTIPLE SURGEONS HAVE NOTED THAT EXOFIN TAKES SIGNIFICANTLY LONGER TO POLYMERIZE COMPARED TO DERMABOND. THEY HAVE ALSO NOTICED AN INCREASE IN PATIENT COMPLAINTS OF ITCHING, BURNING, AND LOCAL IRRITATION AT INCISION SITES, ALONG WITH SEVERAL SUSPECTED ALLERGIC TYPE REACTIONS NECESSITATING OFFICE AND ED VISITS.
Patient problems: Contact Dermatitis; Itching Sensation; Skin Burning Sensation
MAUDE report 24861905 ↗
MalfunctionAug 24, 2020Detachment of Device or Device Component; Detachment of Device or Device Component
THE USER STATED THAT PART OF THE APPLICATOR CONNECTOR PIECE BROKE OFF DURING A PROCEDURE.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 10441687 ↗

Device details

UDI-DI	`00854137001153`
Brand	exofin MICRO HVTSA, 0.5g
Model	EX71010
Company	Chemence Medical, Inc.
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	Dec 15, 2025

Device type (GMDN): Skin-approximation adhesive

A sterile biodegradable glue made of synthetic polymer (e.g., cyanoacrylate) intended for topical closure of surgical incisions and simple traumatic lacerations that have easily-approximated skin edges; it is not intended for internal surgical applications. After application, this device cannot be reused.

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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