BEUDAMED
    FDA Adverse Event Summary report: N

    AURA PSG

    MDR report key: 2675678 · Received July 23, 2012

    Report

    Report Number
    2675678
    Date Received
    July 23, 2012
    Date of Event
    July 10, 2012
    Report Date
    July 23, 2012
    Manufacturer
    GRASS TECHNOLOGIES, AN ASTRO-MED, INC. SUBSIDIARY
    Product Code
    GWQ
    Report Source
    User Facility report
    Reporter Location
    AZ, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    UPON REMOVAL OF THE EEG MONITOR ELECTRODES, A 1/2 CM MARK WAS CENTRALLY LOCATED ON THE FOREHEAD WHERE THE ELECTRODE WAS PLACED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 AURA PSG ELECTROENCEPHALOGRAPH, AMBULATORY GWQ GRASS TECHNOLOGIES, AN ASTRO-MED, INC. SUBSIDIARY AURA PSG *

    Patients

    Seq Age Sex Outcome Treatment
    1 19 YR NO OTHER THERAPIES