BEUDAMED
    FDA Adverse Event Other Summary report: N

    THERMOPAD

    MDR report key: 1654380 · Received April 7, 2010

    Report

    Report Number
    1056436-2010-00026
    Event Type
    Other
    Date Received
    April 7, 2010
    Date of Event
    April 6, 2010
    Report Date
    April 7, 2010
    Manufacturer
    ANGIODYNAMICS, INC.
    Product Code
    GEI
    PMA / PMN Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Description of Event or Problem · 1

    PATIENT RECEIVED A 1ST DEGREE BURN MEASURING APPROXIMATELY 5CM BY 3CM ON THE MEDIAL PORTION OF THE RIGHT THIGH FROM A DISPERSIVE ELECTRODE. THE BURN WAS DISCOVERED AFTER THE PROCEDURE WAS COMPLETED DURING REMOVAL OF THE PADS. RFA OF A 3CM LIVER LESION WAS PERFORMED WITH A STARBURST TALON SEMIFLEX NEEDLE. THERMOPADS WERE USED TO GROUND THE PATIENT. THERMOPAD TEMPERATURES WERE MONITORED THROUGHOUT THE PROCEDURE. THE HIGHEST THERMOPAD TEMPERATURE OBSERVED WAS 35 DEGREES C.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 THERMOPAD RFA PAD GEI ANGIODYNAMICS, INC. NA Y051909-1

    Patients

    Seq Age Sex Outcome Treatment
    1 Other