BEUDAMED
    FDA Adverse Event Summary report: N

    FORCETRIAD

    MDR report key: 2120339 · Received May 27, 2011

    Report

    Report Number
    2120339
    Date Received
    May 27, 2011
    Date of Event
    May 23, 2011
    Report Date
    May 27, 2011
    Manufacturer
    COVIDIEN VALLEYLAB
    Product Code
    GEI
    Report Source
    User Facility report
    Reporter Location
    MN, US

    Narratives

    Description of Event or Problem · 1

    PATIENT TAKEN TO THE OPERATING ROOM FOR TONSILLECTOMY AND ADENOIDECTOMY. AFTER REMOVING THE TONSILS, A BURN ON THE RIGHT CORNER OF THE PATIENT'S MOUTH WAS IDENTIFIED. THE SURGEON WAS NOTIFIED AND ORDERED AN APPLICATION OF BACITRACIN.======================MANUFACTURER RESPONSE FOR ELECTROSURGICAL UNITS, VARIOUS VALLEYLAB BRANDS (PER SITE REPORTER)======================REGIONAL SALES MANAGER AND SALE REP REPRESENTATIVE CAME ON SITE TO EVALUATE SITUATION. NO CAUSE FOR BURN WAS IMMEDIATELY IDENTIFIED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 FORCETRIAD ELECTROSURGICAL GENERATOR GEI COVIDIEN VALLEYLAB * *
    2 HANDSWITCHING PENCIL ELECTROSURGICAL PENCIL GEI COVIDIEN VALLEYLAB * *
    3 SUCTION COAGULATOR SUCTION COAGULATOR GEI COVIDIEN VALLEYLAB * *

    Patients

    Seq Age Sex Outcome Treatment
    1 6 YR