BEUDAMED
    FDA Adverse Event Other Summary report: N

    STERI-SYSTEM SUCTION CAUTERY PENCIL

    MDR report key: 468914 · Received May 22, 2003

    Report

    Report Number
    1042100-2003-00001
    Event Type
    Other
    Date Received
    May 22, 2003
    Date of Event
    April 9, 2003
    Report Date
    May 22, 2003
    Manufacturer
    DURDEN ENTERPRISES, INC.
    Product Code
    GEI
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Description of Event or Problem · 1

    PT RECEIVED MINOR BURN DURING AN ENT SURGICAL PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 STERI-SYSTEM SUCTION CAUTERY PENCIL ELECTROSURGICAL PENCIL GEI DURDEN ENTERPRISES, INC. * 823

    Patients

    Seq Age Sex Outcome Treatment
    1 * Other