BEUDAMED
    FDA Adverse Event Summary report: N

    FORCETRIAD

    MDR report key: 2120363 · Received May 27, 2011

    Report

    Report Number
    2120363
    Date Received
    May 27, 2011
    Date of Event
    May 9, 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 WAS TAKEN TO THE OPERATING ROOM FOR TAKE-DOWN OF HIS GLOSSOPEXY, CLEFT PALATE REPAIR AND MYRINGOTOMY AND TUBE INSERTION. AT THE END OF THE PROCEDURE, A SMALL BLISTER WAS NOTED IN LEFT CORNER OF THE MOUTH. APPROXIMATELY FOUR HOURS LATER, THE BLISTER WAS GONE AND THE AREA WAS RED IN APPEARANCE.======================MANUFACTURER RESPONSE FOR ELECTROSURGICAL GENERATOR, FORCETRIAD (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 * *

    Patients

    Seq Age Sex Outcome Treatment
    1 11 MO NO OTHER THERAPIES