BEUDAMED
    FDA Adverse Event Other Summary report: N

    RITA - RFA - RITA GROUNDING PADS

    MDR report key: 752851 · Received July 7, 2005

    Report

    Report Number
    MW1035996
    Event Type
    Other
    Date Received
    July 7, 2005
    Date of Event
    June 21, 2005
    Report Date
    June 28, 2005
    Manufacturer
    RITA STARBURST ELECTROGICAL DEVICE
    Product Code
    GEI
    Adverse Event
    Yes
    Report Source
    Voluntary report
    Reporter Location
    AR, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    GROUNDING PADS ON ANTERIOR AND POSTERIOR THIGHS BILATERALLY (LENGTH APPROX. 12 INCHES X 6 INCHES) - LEFT POSTERIOR THIGH WITH 1ST DEGREE BURNS, LEFT LATERAL THIGH WITH 1 INCH AREA OF 2ND DEGREE BURNS, MEDIAL ASPECT WITH 2" AREA OF 2ND DEGREE BURN, REST OF ANTERIOR THIGH WITH 1ST DEGREE BURN. RIGHT THIGH ANTERIORLY WITH 5 INCH AREA OF 2ND DEGREE BURN CLOSE TO MEDIAL ASPECT OF THIGH, 1ST DEGREE BURN TO REST OF ANTERIOR THIGH WHERE GROUNDING PAD WAS PLACED. PROCEDURE WAS ABLATION- APPROX. 76 MINUTES- GROUNDING PADS WERE ORIGINALLY PLACED ON ANTERIOR THIGHS BILATERALLY, PATIENT IN PRONE POSITION. PADS WERE MOVED DURING CASE TO POSTERIOR ASPECT OF THIGHS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 RITA - RFA - RITA GROUNDING PADS RADIO FREQ ABLATIONS GEI RITA STARBURST ELECTROGICAL DEVICE * *

    Patients

    Seq Age Sex Outcome Treatment
    1 77 YR Other