BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MASTISOL

    MDR report key: 24273220 · Received February 5, 2026

    Report

    Report Number
    MW5183438
    Event Type
    Malfunction
    Date Received
    February 5, 2026
    Date of Event
    February 1, 2026
    Report Date
    February 1, 2026
    Manufacturer
    FERNDALE LABORATORIES, INC.
    Product Code
    KGX
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Occupation
    RISK MANAGER
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    WHILE PERFORMING A CENTRAL LINE DRESSING CHANGE. WHEN CRACKING MASTISOL IN THE DRESSING CHANGE KIT TO ACTIVATE TO APPLY, THE VIAL COMPLETELY SHATTERED IN MY HAND, MASTISOL WAS DISPOSED, STERILE GLOVES WERE CHANGED, DRESSING WAS PLACED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    335924 MASTISOL TAPE AND BANDAGE, ADHESIVE KGX FERNDALE LABORATORIES, INC. 24134B

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR Female CENTRAL LINE DRESSING KIT LOT NUMBER: 2025091990 EXPIRATION: 10/31/2026.