BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OMNI PRO

    MDR report key: 2474381 · Received February 23, 2012

    Report

    Report Number
    2474381
    Event Type
    Injury
    Date Received
    February 23, 2012
    Date of Event
    February 14, 2012
    Report Date
    February 22, 2012
    Manufacturer
    CARDIOTONICS, INC
    Product Code
    GWQ
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    KY, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    POSSIBLE BURN (0.75) NOTED TO RIGHT TEMPLE OF PT'S FOREHEAD FOLLOWING A EEG EXAM. THE STAFF MEMBERS NOTED THAT NO SKIN PROBLEMS WERE NOTED UNDER THE ELECTRODE WHEN THE PT COMPLAINED OF BURNING. A BROWN SPOT WAS FOUND BELOW WHERE THE ELECTRODE WAS LOCATED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 OMNI PRO OMNIPRO/OMNI AMP (GWQ) GWQ CARDIOTONICS, INC 360-8300 REVISION A NA

    Patients

    Seq Age Sex Outcome Treatment
    1 46 YR NO