BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VALLEYLAB

    MDR report key: 540359 · Received July 29, 2004

    Report

    Report Number
    MW1032869
    Event Type
    Injury
    Date Received
    July 29, 2004
    Date of Event
    July 23, 2004
    Report Date
    July 29, 2004
    Manufacturer
    VALLEYLAB, INC.
    Product Code
    GEI
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    KS, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Description of Event or Problem · 1

    ESU PENCIL THAT ACTIVATED UPON PLUGGING IT INTO THE ESU DEVICE. THIS WAS WITHOUT PRESSING THE ACTIVATION SWITCH. PT BURN -1 BY 2.5 CM- 3RD DEGREE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 VALLEYLAB ESU PENCIL GEI VALLEYLAB, INC. * 81767 2009-05

    Patients

    Seq Age Sex Outcome Treatment
    1 50 YR Hospitalization| R