BEUDAMED
    FDA Adverse Event Injury Summary report: N

    COOL-TIP RF SING, 20CMX2CM KIT

    MDR report key: 1001955 · Received February 20, 2008

    Report

    Report Number
    1717344-2008-00056
    Event Type
    Injury
    Date Received
    February 20, 2008
    Date of Event
    January 31, 2008
    Report Date
    February 4, 2008
    Manufacturer
    COVIDIEN LP, (VALLEYLAB)
    Product Code
    GEI
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    TO DATE THE INCIDENT SAMPLE HAS NOT BEEN REC'D FOR EVAL. IF THE SAMPLE IS REC'D OR IF ADDITIONAL INFO PERTINENT TO THE INCIDENT IS OBTAINED, A FOLLOW-UP REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    THE REPORT STATED THAT DURING A RADIO FREQUENCY ABLATION PROCEDURE, THE SKIN WHERE THE NEEDLE ELECTRODE WAS INSERTED REC'D A 3RD DEGREE BURN. THE BURN WAS TREATED WITH THE EXTERNAL USE OF STEROID AND ANTIBIOTIC OINTMENT. THE PT LEFT THE HOSP IN 2008.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 COOL-TIP RF SING, 20CMX2CM KIT ELECTROSURGICAL ACCESSORY GEI COVIDIEN LP, (VALLEYLAB) 122150

    Patients

    Seq Age Sex Outcome Treatment
    1 66 YR Other