BEUDAMED
    FDA Adverse Event Injury Summary report: N

    STERILE E-Z CLEAN 2 1/2" BLADE ELECTRODE MODIFIED

    MDR report key: 115329 · Received July 31, 1997

    Report

    Report Number
    115329
    Event Type
    Injury
    Date Received
    July 31, 1997
    Date of Event
    February 5, 1997
    Report Date
    February 11, 1997
    Manufacturer
    MEGA DYNE MEDICAL PRODUCTS, INC.
    Product Code
    GEI
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    KY, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    DURING LARYNGOSCOPY, BRONCHOSCOPY AND LASER EXCISION OF VOCAL CORD PAPILLOMAS, THERE WAS SPONTANEOUS IGNITION OF THE INSULATION ON THE TONSIL BOVIE TIP WITH SUBSEQUENT FLAMING OF THE RUBBER TIP (PLASTIC PADDING) ON THE ORAL RETRACTOR, BOTH WERE REMOVED PROMPTLY AND THERE WAS NO PT CONTACT WITH THE FLAME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 STERILE E-Z CLEAN 2 1/2" BLADE ELECTRODE MODIFIED TONSIL BOVIE TIP GEI MEGA DYNE MEDICAL PRODUCTS, INC. * 2272

    Patients

    Seq Age Sex Outcome Treatment
    1 18 MO Life Threatening| O (LOT 28058)| VALLEY LAB HANDSWITCHING PENCIL (MODEL E2515H)