BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FORCE FX-CS

    MDR report key: 2081825 · Received May 3, 2011

    Report

    Report Number
    MW5020506
    Event Type
    Injury
    Date Received
    May 3, 2011
    Date of Event
    April 18, 2011
    Report Date
    May 3, 2011
    Manufacturer
    COVIDIEN VALLEYLAB
    Product Code
    GEI
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    MO, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    THIS PT HAD A LEFT VIDEO-ASSISTED THORACIC SURGERY, LEFT UPPER LOBECTOMY, THORACIC LYMPHADENECTOMY. ELEVEN HOURS AFTER THE SURGERY, THE PT COMPLAINED OF HIS RIGHT THIGH HURTING. THE AREA WAS REDDENED. THE NEXT DAY, THE PT'S SKIN WAS BLISTERED. THE SKIN WAS TREATED WITH SILVADENE. THE MACHINE WAS EVALUATED BY CLINICAL ENGINEERING AND IT WAS FOUND TO BE IN GOOD WORKING ORDER ACCORDING TO THE MANUFACTURE SPECIFICATIONS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 FORCE FX-CS BOVIE MACHINE GEI COVIDIEN VALLEYLAB FORCE FX-CS

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR Disability