BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NEUROTHERM DISPOSAL RF CANNULA

    MDR report key: 4309181 · Received December 1, 2014

    Report

    Report Number
    3002953813-2014-00019
    Event Type
    Injury
    Date Received
    December 1, 2014
    Date of Event
    October 15, 2014
    Report Date
    October 31, 2014
    Manufacturer
    NEUROTHERM, INC.
    Product Code
    GXD
    PMA / PMN Number
    K052878
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AR, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE GENERATOR WAS RETURNED FOR EVALUATION. TESTING REVEALED NO ABNORMALITIES. MANUFACTURING RECORD REVIEW FOR ALL PRODUCT INVOLVED IN THE EVENT WAS CONDUCTED AND NO ABNORMALITIES WERE FOUND. THE CAUSE OF THE REPORTED BURN REMAINS UNKNOWN.

    Description of Event or Problem · 1

    DURING A RADIOFREQUENCY ABLATION PROCEDURE, BURNS OCCURRED ON THE PATIENT'S FOOT AT THE SITE WHERE THE CANNULA WAS INSERTED. THE BURN WAS TREATED WITH ANTIBIOTICS AND SILVADENE CREAM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    774146 NEUROTHERM DISPOSAL RF CANNULA DISPOSABLE RF CANNULA GXD NEUROTHERM, INC. S-505

    Patients

    Seq Age Sex Outcome Treatment
    1