BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NEUROSIGN

    MDR report key: 375080 · Received February 1, 2002

    Report

    Report Number
    8021774-2002-00001
    Event Type
    Injury
    Date Received
    February 1, 2002
    Report Date
    February 1, 2002
    Manufacturer
    THE MAGSTIM COMPANY LTD.
    Product Code
    ETN
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    HK
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    DURING A SURGICAL OPERATION, BURNING MARKS WERE FOUND ON THE PATIENTS BODY NEAR THE AREA WHERE THE NEEDLE ELECTRODES WERE INSERTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 NEUROSIGN 2 CHANNEL MOTOR NERVE MONITOR ETN THE MAGSTIM COMPANY LTD. SEE ATTACHED SHEET *

    Patients

    Seq Age Sex Outcome Treatment
    1 75 YR Other