BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BOVIE FORCE FX

    MDR report key: 1071078 · Received July 8, 2008

    Report

    Report Number
    MW5007540
    Event Type
    Injury
    Date Received
    July 8, 2008
    Date of Event
    June 1, 2008
    Report Date
    July 2, 2008
    Manufacturer
    VALLEY LAB (NOW COVIDIEN)
    Product Code
    GEI
    Adverse Event
    Yes
    Report Source
    Voluntary report
    Reporter Location
    AK, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    DURING EMERGENCY TRACHEOSTOMY PROCEDURE IN OR, WHILE SURGEON STARTED USING NEEDLE TIP CAUTERY, THERE WAS A FLASH FIRE IGNITING THE DRAPES. IT WAS SMOTHERED WITH TOWELS AND DRAPES, THEY FLARED UP AGAIN. PT SUFFERED DEEP SECOND DEGREE BURNS, FACE, RIGHT EAR AND RIGHT SHOULDER. THIS PT HAD A LARGE PRESUMPTIVE CANCER OF LARYNX - PREVENTING INTUBATION SO FACE MASK HAD TO BE USED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BOVIE FORCE FX NONE GEI VALLEY LAB (NOW COVIDIEN) * *

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR Hospitalization| L| R HUDSON RCI OXYGEN MASK