BEUDAMED
    FDA Adverse Event Summary report: N

    CASCADE ELITE

    MDR report key: 2497872 · Received March 16, 2012

    Report

    Report Number
    2497872
    Date Received
    March 16, 2012
    Date of Event
    January 25, 2012
    Report Date
    March 16, 2012
    Manufacturer
    CADWELL LABORATORIES INC.
    Product Code
    GWE
    Report Source
    User Facility report
    Reporter Location
    OH, US

    Narratives

    Description of Event or Problem · 1

    A BURN RESULTED FROM A EEG GROUND PAD ON THE PATIENT ON THE LOWER LEFT EXTREMITY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CASCADE ELITE STIMULATOR, ELECTRICAL, NEUROMUSCULAR GWE CADWELL LABORATORIES INC. CASCADE ELITE *

    Patients

    Seq Age Sex Outcome Treatment
    1 13 YR