BEUDAMED
    FDA Adverse Event Injury Summary report: N

    COOL-TIP SINGLE ELECTRODE 15CM X 2CM KIT

    MDR report key: 1890052 · Received November 1, 2010

    Report

    Report Number
    1717344-2010-00738
    Event Type
    Injury
    Date Received
    November 1, 2010
    Date of Event
    October 6, 2010
    Report Date
    October 8, 2010
    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

    (B)(4). THE INCIDENT SAMPLE HAS BEEN REQUESTED, BUT TO DATE HAS NOT BEEN RECEIVED FOR EVAL. IF THE SAMPLE IS RECEIVED, OR IF ADDITIONAL INFO PERTINENT TO THE INCIDENT IS OBTAINED, A F/U REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT BEFORE INSERTING THE NEEDLE INTO THE PT, THE OPERATOR ACTIVATED THE NEEDLE BY MISTAKE, RESULTING IN A BURN TO THE PT. THE BURN WAS DESCRIBED AS 3RD DEGREE AND TREATED WITH CONSERVATIVE MEASURES. THE PT'S STATUS WAS REPORTED TO BE FINE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 COOL-TIP SINGLE ELECTRODE 15CM X 2CM KIT RF ABLATION ACCESSORY GEI COVIDIEN LP (VALLEYLAB) 168571

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Other