BEUDAMED
    FDA Adverse Event Injury Summary report: N

    COOL-TIP RF SING, 20CMX2CM KIT

    MDR report key: 788353 · Received November 28, 2006

    Report

    Report Number
    1717344-2006-00325
    Event Type
    Injury
    Date Received
    November 28, 2006
    Date of Event
    October 12, 2006
    Report Date
    October 30, 2006
    Manufacturer
    VALLEYLAB QA
    Product Code
    GEI
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    PROCEDURE: RADIOFREQUENCY ABLATION. REPORTEDLY, AFTER A PROCEDURE WHEN THE RETURN ELECTRODE PAD WAS REMOVED, A THIRD DEGREE BURN WAS CONFIRMED. THE TISSUE WAS TREATED WITH DEBRIDEMENT. SCARRING OF THE TISSUE IS LIKELY TO OCCUR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 COOL-TIP RF SING, 20CMX2CM KIT ELECTROSURGICAL DEVICE GEI VALLEYLAB QA * 94900

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Required Intervention