BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SUCTION CAUTERY PENCIL

    MDR report key: 40042 · Received September 5, 1996

    Report

    Report Number
    1042100-1996-09001
    Event Type
    Malfunction
    Date Received
    September 5, 1996
    Date of Event
    August 22, 1996
    Report Date
    August 22, 1996
    Manufacturer
    DURDEN ENTERPRISES, INC.
    Product Code
    GEI
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Description of Event or Problem · 1

    NO DEATH OR SERIOUS INJURY OCCURRED. PRODUCT #103-8575, LOT #661 HAS BEEN TESTED AND NO DEFECTS FOUND. NO ADD'L INFO WILL BE SUBMITTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SUCTION CAUTERY PENCIL SUCTION CAUTERY PENCIL GEI DURDEN ENTERPRISES, INC. 103-8575 661

    Patients

    Seq Age Sex Outcome Treatment
    1 *