BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HI PWR DISPOSBL GRNDING PAD

    MDR report key: 929276 · Received October 16, 2007

    Report

    Report Number
    1717344-2007-00342
    Event Type
    Malfunction
    Date Received
    October 16, 2007
    Date of Event
    September 13, 2007
    Report Date
    September 21, 2007
    Manufacturer
    VALLEYLAB
    Product Code
    GEI
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    DATE OF INITIAL REPORT: 10/16/2007. THE SAMPLE IS CURRENTLY UNDER EVALUATION. WHEN THE INVESTIGATION IS COMPLETE, A FOLLOW-UP REPORT WILL BE SENT.

    Description of Event or Problem · 1

    THE REPORT STATED THAT SOON AFTER STARTING THE RADIO FREQUENCY ABLATION PROCEDURE, THE PATIENT COMPLAINED OF HEAT ON THEIR THIGH, WHERE THE PATIENT RETURN ELECTRODE PAD WAS ATTACHED. THE DOCTOR STOPPED THE ABLATION TO CHECK AND CONFIRMED 1CM RED BURN AT THE LOCATION. THE DOCTOR CHANGED TO A NEW PAD AND COMPLETED THE PROCEDURE. BURN WAS TREATED IMMEDIATELY AFTER THE PROCEDURE AND IT WAS REGARDED AS MINOR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HI PWR DISPOSBL GRNDING PAD ELECTROSURGICAL ACCESSORY GEI VALLEYLAB UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 YR