BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MASTISOL LIQUID ADHESIVE NET 2.3 ML

    MDR report key: 3603282 · Received January 29, 2014

    Report

    Report Number
    MW5034127
    Event Type
    Malfunction
    Date Received
    January 29, 2014
    Date of Event
    January 25, 2014
    Report Date
    January 28, 2014
    Manufacturer
    FERNDALE LABORATORIES, INC.
    Product Code
    KGX
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    PA, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    MASTISOL WAS OPENED ON THE SURGICAL FIELD AND CRACKED BY THE O.R. TECHNICIAN. MASTISOL WAS HANDED TO THE SURGEON FOR USE. UPON USE, IT WAS DISCOVERED THE GLASS INSIDE THE TUBE HAD PIERCED THROUGH THE OUTER PLASTIC AND CUT THE SURGEON'S THUMB. NO SUTURES WERE REQUIRED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    62695 MASTISOL LIQUID ADHESIVE NET 2.3 ML LIQUID ADHESIVE KGX FERNDALE LABORATORIES, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 Other