BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SUCTION CAUTERY PENCIL

    MDR report key: 52933 · Received November 22, 1996

    Report

    Report Number
    1042100-1996-09002
    Event Type
    Malfunction
    Date Received
    November 22, 1996
    Date of Event
    November 13, 1996
    Report Date
    November 22, 1996
    Manufacturer
    DURDEN ENTERPRISES, INC.
    Product Code
    GEI
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    INVALID DATA

    Narratives

    Description of Event or Problem · 1

    NO DEATH OR SERIOUS INJURY OCCURED. PAST HISTORY HAS SHOWN THESE INCIDENTS ARE POSSIBLY CAUSED BY USER ERROR. ADD'L INVESTIGATION WILL BE COMPLETED WHEN THE PART IS RETURNED BY THE USER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SUCTION CAUTERY PENCIL SUCTION CAUTERY PENCIL GEI DURDEN ENTERPRISES, INC. 103-4575 # 1254

    Patients

    Seq Age Sex Outcome Treatment
    1 *