BEUDAMED
    FDA Adverse Event Other Summary report: N

    THERMOPAD

    MDR report key: 2163691 · Received June 14, 2011

    Report

    Report Number
    1056436-2011-00024
    Event Type
    Other
    Date Received
    June 14, 2011
    Date of Event
    April 4, 2011
    Report Date
    June 14, 2011
    Manufacturer
    ANGIODYNAMICS
    Product Code
    GEI
    PMA / PMN Number
    NA
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Description of Event or Problem · 1

    THE PT WAS UNDERGOING A RADIO-FREQUENCY ABLATION PROCEDURE WHEN IT WAS NOTED THAT THE GROUNDING PADS WERE HEATING BEYOND ACCEPTABLE LIMITS. THE PT'S LEFT THIGH SKIN PEELED AT THE TOP OF THE PAD WHEN REMOVED. AREA WAS APPROX 3-INCH BY 1-INCH OF SKIN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 THERMOPAD RFA PAD GEI ANGIODYNAMICS NA Y072610-05

    Patients

    Seq Age Sex Outcome Treatment
    1 Other