BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VALLEY LAB BOVIE FORCE FX

    MDR report key: 3360129 · Received September 16, 2013

    Report

    Report Number
    MW5031865
    Event Type
    Injury
    Date Received
    September 16, 2013
    Date of Event
    September 5, 2013
    Report Date
    September 10, 2013
    Manufacturer
    COVIDIEN
    Product Code
    GEI
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    TX, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    PT UNDERWENT PORT-A-CATH REMOVAL ON (B)(6) 2013. DURING PROCEDURE, THE BOVIE REM ALARMED AND THE REM LIGHT APPEARED. THE ORIGINAL BOVIE PAD WAS DISCONNECTED FROM THE PTS LEFT UPPER ANTERIOR THIGH AND A NEW PAD WAS PLACED ON PT'S RIGHT BACK. POST PROCEDURE A REDDENED AREA WITH BLISTERS AND A SMALL AMOUNT OF SKIN LOSS WAS DISCOVERED AT THE ORIGINAL BOVIE SITE. BACITRACIN OINTMENT AND XEOFORM GAUZE WAS PLACED OVER THE AFFECTED AREA. FREQUENCY AND ROUTE USED: (L) UPPER/ANTERIOR THIGH. DIAGNOSIS FOR USE: ORTHOPEDIC SURGERY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    465036 VALLEY LAB BOVIE FORCE FX BOVIE FORCE FX GEI COVIDIEN 069-02659 32210062X

    Patients

    Seq Age Sex Outcome Treatment
    1 61 YR Required Intervention