BEUDAMED
    FDA Adverse Event Other Summary report: N

    BOSTON SCIENTIFIC

    MDR report key: 528259 · Received May 19, 2004

    Report

    Report Number
    MW1032129
    Event Type
    Other
    Date Received
    May 19, 2004
    Date of Event
    April 28, 2004
    Report Date
    May 10, 2004
    Manufacturer
    BOSTON SCIENTIFIC
    Product Code
    LPB
    Report Source
    Voluntary report
    Reporter Location
    LA, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    RF3000 GENERATOR WAS ON LOAN FROM VENDOR AND WAS BEING USED DURING A PROCEDURE. FOUR BOVIE PADS WERE PLACED AT THE SAME LEVEL PER THE EQUIPMENT REP'S INSTRUCTIONS. ONCE PHYSICIAN FINISHED WITH EQUIPMENT THE PADS WERE REMOVED. PT'S UPPER THIGHS WERE NOTED TO BE BURNED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BOSTON SCIENTIFIC GENERATOR RF 3000 LPB BOSTON SCIENTIFIC * 010304

    Patients

    Seq Age Sex Outcome Treatment
    1 78 YR Other