BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LAB BOVIE PENCIL

    MDR report key: 1031489 · Received April 17, 2008

    Report

    Report Number
    MW5006290
    Event Type
    Malfunction
    Date Received
    April 17, 2008
    Date of Event
    March 26, 2008
    Report Date
    April 17, 2008
    Manufacturer
    COVIDIEN VALLEY
    Product Code
    GEI
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    SC, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    DISPOSABLE BOVIE PENCIL CAUSED FIRE HAZARD. DISPOSABLE BOVIE LOT# 131269 IGNITED AND CHARRED RAYTEC SPONGE. ALL OTHER EQUIPMENT IN THE OR WAS CHECKED AND THE DISPOSABLE BOVIE WAS IDENTIFIED AS THE CAUSE. THIS ITEM WAS CHANGED TWICE, A NEW DISPOSABLE BOVIE PENCIL WITH A DIFFERENT LOT NUMBER WAS USED WITHOUT PROBLEM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LAB BOVIE PENCIL GEI COVIDIEN VALLEY E2515H 131269

    Patients

    Seq Age Sex Outcome Treatment
    1 71 YR