BEUDAMED
    FDA Adverse Event Injury Summary report: N

    H-WAVE

    MDR report key: 7956337 · Received October 10, 2018

    Report

    Report Number
    MW5080461
    Event Type
    Injury
    Date Received
    October 10, 2018
    Date of Event
    October 6, 2018
    Report Date
    October 8, 2018
    Manufacturer
    ELECTRONIC WAVEFORM LAB, INC.
    Product Code
    GZJ
    Adverse Event
    Yes
    Report Source
    Voluntary report
    Reporter Location
    MO, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    STARTED USING H-WAVE AND HEADACHE INCREASED. FLOATERS STARTED AGAIN IN LEFT EYE, NERVE SENSATIONS ON HEAD AND SCALP WON'T TURN OFF NOW. HAD BEEN BETTER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    795545 H-WAVE STIMULATOR, NERVE, TRANSCUTANEOUS FOR PAIN RELIEF GZJ ELECTRONIC WAVEFORM LAB, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 43 YR Other