Skip to content

Exofin Fusion Skin Closure System 22cmRecalls & reported problems

Chemence Medical, Inc. · Cutaneous Tissue Adhesive With Mesh · Class 2

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 00854137001238), received between Oct 18, 2018 and Oct 18, 2018 — classified as 1 injury.

The most frequently reported specific device problem is “Material Fragmentation” (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.

Most reported problems

Device problems

  • Material Fragmentation1

Patient problems

  • Sepsis1

Recent adverse event reports

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

  • InjuryOct 18, 2018Material Fragmentation

    IT WAS REPORTED THAT A PATIENT DEVELOPED "SEPTIC TOTAL KNEE REQUIRING IRRIGATION AND DEBRIDEMENT". THE PATIENT HAD BEEN TREATED USING EXOFIN FUSION FOLLOWING SURGERY.

    Patient problems: Sepsis

    MAUDE report 7978808 ↗

Other Cutaneous Tissue Adhesive With Mesh devices

All Cutaneous Tissue Adhesive With Mesh devices →

Sources and updates

How reports and recalls are matched · Editorial policy · Report an error on this page