BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MEGADYNE

    MDR report key: 6986482 · Received October 30, 2017

    Report

    Report Number
    6986482
    Event Type
    Malfunction
    Date Received
    October 30, 2017
    Date of Event
    October 23, 2017
    Report Date
    October 24, 2017
    Manufacturer
    MEGADYNE MEDICAL PRODUCTS, INC.
    Product Code
    GEI
    UDI-DI
    10614559100493
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    UT, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    PLUGGED IN BOVIE AND IT ACTIVATED ON ITS OWN. UNPLUGGED IT, AND MADE SURE BUTTON WAS NOT BEING DEPRESSED AND PLUGGED IT BACK IN. IT ACTIVATED AGAIN BUT THE STAFF TOOK THE BOVIE OFF THE FIELD AND REPLACED WITH ANOTHER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    768737 MEGADYNE ELECTROSURGICAL, CUTTING, COAGULATION & ACCESSORIES GEI MEGADYNE MEDICAL PRODUCTS, INC. 0035H 1606094 10614559100493

    Patients

    Seq Age Sex Outcome Treatment
    1 36 YR