BEUDAMED
    FDA Adverse Event Other Summary report: N

    BIRTCHER 4400

    MDR report key: 1100550 · Received August 5, 2008

    Report

    Report Number
    MW5007896
    Event Type
    Other
    Date Received
    August 5, 2008
    Date of Event
    June 23, 2008
    Report Date
    July 18, 2008
    Manufacturer
    CONMED, CORP.
    Product Code
    GEI
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    SC, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    SUPERFICIAL <2MM BURN TO PATIENT DURING PROCEDURE. HANDPIECE (FOVIE) FOUND TO BE FAULTY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BIRTCHER 4400 HANDHELD BOVIE GEI CONMED, CORP. * 0804242

    Patients

    Seq Age Sex Outcome Treatment
    1 4 YR Other