BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NEUROSIGN

    MDR report key: 821103 · Received February 23, 2007

    Report

    Report Number
    8021774-2007-00001
    Event Type
    Injury
    Date Received
    February 23, 2007
    Report Date
    February 23, 2007
    Manufacturer
    THE MAGSTIM COMPANY LTD.
    Product Code
    ETN
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AU
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Description of Event or Problem · 1

    DURING A SURGICAL OPERATION USING THE 'NEUROSIGN 100', BURN MARKS WERE FOUND ON THE PT'S BODY NEAR THE AREA WHERE THE NEEDLE ELECTRODES ASSOCIATED WITH THE MACHINE WERE INSERTED. THIS INCIDENT OCCURRED IN ANOTHER COUNTRY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 NEUROSIGN NEUROSIGN 100 (MOTO NERVE MONITOR ETN) ETN THE MAGSTIM COMPANY LTD. 9883-00 *

    Patients

    Seq Age Sex Outcome Treatment
    1 * Other