BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EMG NEEDLE ELECTRODE

    MDR report key: 5018920 · Received August 20, 2015

    Report

    Report Number
    5018920
    Event Type
    Malfunction
    Date Received
    August 20, 2015
    Date of Event
    April 27, 2015
    Report Date
    April 28, 2015
    Manufacturer
    CHALGREN ENTERPRISES, INC.
    Product Code
    GXZ
    Adverse Event
    Yes
    Report Source
    User Facility report
    Reporter Location
    MO, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    AN ELECTRODE PLACED INTO THORACIC SPINE. RUNNING BASELINE DATA ELECTRODE SMOKE MELTED AT CORD CAUSING RAYTEC TO CATCH FIRE. NO FIRE ON DRAPE. RAYTEC TO FLOOR AND SALINE PLACED ON FLOOR PUTTING FIRE OUT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    550651 EMG NEEDLE ELECTRODE ELECTRODE, NEEDLE GXZ CHALGREN ENTERPRISES, INC. 126-412-36TP Y259

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR