BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HANDSWITCHING ROCKER SWITCH PENCIL

    MDR report key: 1082309 · Received July 3, 2008

    Report

    Report Number
    1082309
    Event Type
    Injury
    Date Received
    July 3, 2008
    Date of Event
    June 24, 2008
    Report Date
    June 26, 2008
    Manufacturer
    COVIDIEN VALLEYLAB
    Product Code
    GEI
    Adverse Event
    Yes
    Report Source
    User Facility report
    Reporter Location
    WI, US
    Reporter Occupation
    INVALID DATA

    Narratives

    Description of Event or Problem · 1

    AN ALTERNATE SITE BURN OCCURRED AT THE LEFT CORNER OF THE PATIENT'S MOUTH DURING A TONSILLECTOMY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HANDSWITCHING ROCKER SWITCH PENCIL ESU, PENCIL GEI COVIDIEN VALLEYLAB * 138718 2013-03
    2 FORCE 2 ESU, GENERATOR GEI COVIDIEN VALLEYLAB FORCE 2 - 2PCH *
    3 E-Z CLEAN BLADE ELECTRODES ESU, ELECTRODE GEI MEGADYNE MEDICAL PRODUCTS, INC. * 2012-11 72041

    Patients

    Seq Age Sex Outcome Treatment
    1 5 YR Required Intervention NO OTHER THERAPIES| NO OTHER THERAPIES