BEUDAMED
    FDA Adverse Event Other Summary report: N

    103 4575 SUCTION CAUTERY PENCIL

    MDR report key: 524891 · Received May 10, 2004

    Report

    Report Number
    1042100-2004-00001
    Event Type
    Other
    Date Received
    May 10, 2004
    Date of Event
    April 7, 2004
    Report Date
    May 6, 2004
    Manufacturer
    DURDEN ENTERPRISES, INC.
    Product Code
    GEI
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    INVALID DATA

    Narratives

    Description of Event or Problem · 1

    THE PT WAS BURNED ON THE LIP AND TONGUE DUE TO A HOLE IN THE INSULATION ON A SUCTION CAUTERY PENCIL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 103 4575 SUCTION CAUTERY PENCIL SUCTION CAUTERY PENCIL GEI DURDEN ENTERPRISES, INC. * 1034

    Patients

    Seq Age Sex Outcome Treatment
    1 7 YR Other