BEUDAMED
    FDA Adverse Event Other Summary report: N

    103-4575 PENCIL

    MDR report key: 5885953 · Received July 27, 2004

    Report

    Report Number
    1042100-2004-00002
    Event Type
    Other
    Date Received
    July 27, 2004
    Date of Event
    May 1, 2004
    Report Date
    July 27, 2004
    Manufacturer
    DURDEN ENTERPRISES, INC./ STERI SYSTEMS
    Product Code
    GEI
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE PASSED INSPECTION ON THE DIELECTRIC TESTER BEFORE BEING STERILIZED AND PASSED VISUAL INSPECTION PRIOR TO SHIPPING. IT IS UNKNOWN HOW THE INSULATION WAS DAMAGED.

    Description of Event or Problem · 1

    PATIENT RECEIVED A BURN ON THE LIP.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 103-4575 PENCIL SUCTION CAUTERY PENCIL GEI DURDEN ENTERPRISES, INC./ STERI SYSTEMS 241

    Patients

    Seq Age Sex Outcome Treatment
    1 Other