BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    *

    MDR report key: 2140683 · Received June 9, 2011

    Report

    Report Number
    2140683
    Event Type
    Malfunction
    Date Received
    June 9, 2011
    Date of Event
    June 6, 2011
    Report Date
    June 9, 2011
    Manufacturer
    COVIDIEN
    Product Code
    GEI
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    TX, US

    Narratives

    Description of Event or Problem · 1

    THE BOVIE UNIT WAS PLACED ON THE DRAPE AND IT WAS NOTED TO BE SPARKING. UPON INSPECTION, THERE WAS A 1 CM BURN IN THE DRAPE AND THE PATIENT'S LEFT KNEE CAP.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 * BOVIE UNIT GEI COVIDIEN * *

    Patients

    Seq Age Sex Outcome Treatment
    1 72 YR