BEUDAMED
    FDA Adverse Event Other Summary report: N

    NEUROSIGN 100 NERVE MONITOR

    MDR report key: 230046 · Received July 2, 1999

    Report

    Report Number
    1037007-1999-00002
    Event Type
    Other
    Date Received
    July 2, 1999
    Report Date
    July 2, 1999
    Manufacturer
    MAGSTIM CO. LTD.
    Product Code
    JXE
    Adverse Event
    Yes
    Report Source
    Distributor report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    REPORTEDLY DURING SURGERY, A PHYSICIAN SEVERED A FACIAL NERVE WHILE USING THE NEUROSIGN EQUIPMENT. THE EQUIPMENT WAS RETURNED TO SMITH & NEPHEW, INC., ENT DIVISION FOR EVALUATION AT THE REQUEST OF THE HOSPITAL. THE UNIT WAS EVALUATED AND NO PROBLEMS WITH THE UNIT WERE FOUND. THE UNIT WILL BE RETURNED TO THE HOSPITAL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 NEUROSIGN 100 NERVE MONITOR NERVE MONITOR JXE MAGSTIM CO. LTD. * *

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Other