BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CASCADE EMG/EP/EEG IOM

    MDR report key: 5952204 · Received September 15, 2016

    Report

    Report Number
    5952204
    Event Type
    Malfunction
    Date Received
    September 15, 2016
    Date of Event
    April 28, 2016
    Report Date
    September 1, 2016
    Manufacturer
    CADWELL INDUSTRIES, INC.
    Product Code
    GWE
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    AZ, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    AT THE END OF THE SPINAL CASE, THE VENDOR NOTED BURNS AT THE SITES OF THE NEUROSTIMULATOR ELECTRODE PINS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    605368 CASCADE EMG/EP/EEG IOM STIMULATOR, PHOTIC, EVOKED RESPONSE GWE CADWELL INDUSTRIES, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 61 YR Other MULITPLE DEVICES IN THE ROOM: AQUA MANTUS, STRYKER