exofin Mastic, 0.67ml EM80148Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00854137001696), received between Jun 24, 2026 and Jun 24, 2026 — classified as 1 malfunction.

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.

Most reported problems

Recent adverse event reports

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

• MalfunctionJun 24, 2026Insufficient Device Problem Information

  MEDWATCH REPORT MW5188831 RECEIVED INDICATING: "EMPLOYEE PROFESSIONAL STAFF NURSE, EXPERT - IV THERAPY, ON (5/19) NOTIFIED CLINICIAN IV THERAPY THAT SHE EXPERIENCED A MEDICAL DEVICE-RELATED INJURY WHILE SEEING A PATIENT. WHEN PREPARING IV SUPPLIES, RN OPENED AND APPLIED PRESSURE TO THE APPLICATOR ON A EXOFIN MASTIC LIQUID ADHESIVE VIAL .67ML, UNSPSC (B)(4), UPMC ITEM #(B)(4). THE INNER PORTION OF THE VIAL IS A GLASS AMPUL THAT IS MEANT TO BREAK AND RELEASE FLUID TO THE SPONGE APPLICATOR. THE GLASS BROKE THROUGH THE PLASTIC APPLICATOR AND CUT RN'S FINGER. NO CONCERNS OF BBP EXPOSURE. ON THE PACKAGE INSERT, IT DOES STATE TO "CRUSH VIAL BEFORE OPENING THIS PACKAGE." NO PATIENT INVOLVEMENT OCCURRED DURING THIS INJURY."

  Patient problems: Abrasion

  MAUDE report 25608120 ↗