BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NEUROTHERM DISPOSABLE RF CANNULA

    MDR report key: 4309171 · Received December 1, 2014

    Report

    Report Number
    3002953813-2014-00018
    Event Type
    Injury
    Date Received
    December 1, 2014
    Date of Event
    September 30, 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. PER THE COMMUNICATION DETAILS IN THE FILE, THIS BURN WAS NOT TREATED. SILVADENE AND ABX WERE USED TO TREAT THE TWO SERIOUS BURNS.

    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.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    774349 NEUROTHERM DISPOSABLE RF CANNULA DISPOSABLE RF CANNULA GXD NEUROTHERM, INC. S-505

    Patients

    Seq Age Sex Outcome Treatment
    1 Other