BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HEALY

    MDR report key: 10096340 · Received May 27, 2020

    Report

    Report Number
    MW5094727
    Event Type
    Injury
    Date Received
    May 27, 2020
    Date of Event
    May 7, 2020
    Report Date
    May 26, 2020
    Manufacturer
    TIMEWAVER PRODUCTION GMBH
    Product Code
    NUH
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    CA, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    I PURCHASED THE HEALY. THE WEBSITE IS WWW.HEALYWORLD.NET/IN/WELLNESS VIDEO IS (B)(6) I ORDERED IT ONLINE AND IT ARRIVES IN MY HOME IN (B)(6). IT IS A 'MEDICALLY CERTIFIED' WEARABLE BRACKET THAT CONNECTS TO FREQUENCY GENERATOR. THE PRODUCERS STATED THAT IT COULD HELP WITH MY DEPRESSION. I STOPPED TAKING MY MEDICATION THINKING THE DEVICE COULD REPLACE THEM. AFTER 4 WEEKS MY SYMPTOMS GOT WORSE AND I AM NOW ON A HIGHER DOSE. THIS PRODUCT COMPLETELY FAILED IN ITS THERAPEUTIC CLAIMS. WHEN MY WIFE SAW WHAT WAS HAPPENING TO ME, SHE THREW OUT THE DEVICE AND FORCED ME BACK ON MY MEDICATION. I AM NOW STABLE AGAIN, BUT AT A HIGHER DOSAGE THAN PREVIOUSLY. NOTE: TIMEWAVER AND HEALY (B)(4) ARE (B)(4). MANUFACTURING PARTNERS FOR (B)(4). FDA SAFETY REPORT ID# (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    554252 HEALY STIMULATOR, NERVE, TRANSCUTANEOUS, OVER-THE-COUNTER NUH TIMEWAVER PRODUCTION GMBH

    Patients

    Seq Age Sex Outcome Treatment
    1 38 YR Other