BEUDAMED
    FDA Adverse Event Summary report: N

    (NICOLET) EEG VOYAGEUR

    MDR report key: 263761 · Received February 18, 2000

    Report

    Report Number
    MW1018198
    Date Received
    February 18, 2000
    Date of Event
    February 3, 2000
    Report Date
    February 17, 2000
    Manufacturer
    NICOLET BIOMEDICAL INC.
    Product Code
    GWQ
    Report Source
    Voluntary report
    Reporter Location
    AL, US
    Reporter Occupation
    INVALID DATA

    Narratives

    Description of Event or Problem · 1

    RPTR WAS PERFORMING EEG ON PT AND STEPPED OVER TO POSITION PHOTIC STIMULATION OVER PT'S FACE AND IT FELL INTO PT'S FACE AND NOSE. PT STATED PT WAS OK. THROUGHOUT RECORDING RPTR CONTINUED AND CONSTANTLY ASKED PT HOW PT WAS DOING. AFTER THE EEG WAS OVER RPTR INFORMED MGR AND PT FILLED OUT NECESSARY PAPERS AS DID RPTR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 (NICOLET) EEG VOYAGEUR EEG MACHINE GWQ NICOLET BIOMEDICAL INC. 5003 *

    Patients

    Seq Age Sex Outcome Treatment
    1 39 YR