BEUDAMED
    FDA Adverse Event Other Summary report: N

    OLSEN MEDICAL

    MDR report key: 708159 · Received April 18, 2006

    Report

    Report Number
    MW1038729
    Event Type
    Other
    Date Received
    April 18, 2006
    Date of Event
    April 13, 2006
    Report Date
    April 18, 2006
    Manufacturer
    OLSEN MEDICAL
    Product Code
    GCJ
    Adverse Event
    Yes
    Report Source
    Voluntary report
    Reporter Location
    MO, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    A BOVIE WAS USED OT MAKE AN INCISION ABOUT THE CIRCUMFERENCE OF THE TONSIL. DURING THE INCISION, A BURN WAS NOTED IN THE R LATERAL COMMISSURE. EXAMINE WITH THE BOVIE HANDPIECE REVEALED VIOLATION OF THE INSULATION OF THE BOVIE TIP.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 OLSEN MEDICAL CAUTERY - BLUNT TIP SHORT GCJ OLSEN MEDICAL 66703 113741

    Patients

    Seq Age Sex Outcome Treatment
    1 6 YR Other