BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MASTISOL LIQUID ADHESIVE

    MDR report key: 23582618 · Received November 18, 2025

    Report

    Report Number
    MW5178969
    Event Type
    Malfunction
    Date Received
    November 18, 2025
    Date of Event
    November 3, 2025
    Report Date
    November 13, 2025
    Manufacturer
    FERNDALE LABORATORIES, INC.
    Product Code
    KGX
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    MN, US
    Reporter Occupation
    NURSE
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    THE VIAL SHATTERS WHICH RESULTS IN GLASS SHARDS LANDING ON THE PATIENT. ONE VIAL SHATTERED AND PRODUCT ENDED UP IN THE STAFF MEMBER'S EYE REQUIRING EYE FLUSHING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2236399 MASTISOL LIQUID ADHESIVE TAPE AND BANDAGE, ADHESIVE KGX FERNDALE LABORATORIES, INC. 24161B

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown