BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FOOTSWITCHING SUCTION COAGULATOR

    MDR report key: 1823502 · Received August 27, 2010

    Report

    Report Number
    MW5017262
    Event Type
    Injury
    Date Received
    August 27, 2010
    Date of Event
    July 22, 2010
    Report Date
    August 27, 2010
    Manufacturer
    MEGADYNE
    Product Code
    GEI
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    WY, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    PHYSICIAN USING THE MEGADYNE FOOTSWITCHING SUCTION/COAGULATOR, (B)(4), LOT # 01901, EXPIRES 09/06/2015, DURING A TONSILLECTOMY ADENOIDECTOMY. WITHIN THE FIRST MINUTE OF USE, A FLAME WAS NOTED FROM THE UNIT LASTING APPROXIMATELY 1-1.5 SECONDS WHEN CAUTERIZING TONSIL. THE PATIENT SUFFERED A SUPERFICIAL BURN AND LEFT POSTERIOR TONGUE APPROXIMATELY 3/4 CM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 FOOTSWITCHING SUCTION COAGULATOR NONE GEI MEGADYNE 01901

    Patients

    Seq Age Sex Outcome Treatment
    1 8 YR Other