BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HEALY

    MDR report key: 10361689 · Received August 3, 2020

    Report

    Report Number
    MW5095863
    Event Type
    Injury
    Date Received
    August 3, 2020
    Date of Event
    July 22, 2020
    Report Date
    July 31, 2020
    Manufacturer
    HEALY GMBH
    Product Code
    NUH
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    I PURCHASED THE HEALY HOPING IT WOULD HELP ME WITH MY DEPRESSION. IT DIDN'T WORK FOR ME AT ALL. I (B)(6) THEM YESTERDAY AND SAW THAT THEIR PRODUCT WAS PULLED FROM THE MARKET IN EUROPE. JUST THOUGHT THAT THE FDA SHOULD KNOW IT IS STILL ON SALE IN THE US. HTTPS://WWW.HEALYWORLD.NET/IN/CHOOSE-YOUR-LANGUAGE/. FDA SAFETY REPORT ID # (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    824605 HEALY STIMULATOR, NERVE, TRANSCUTANEOUS, OVER-THE-COUNTER NUH HEALY GMBH HEALY

    Patients

    Seq Age Sex Outcome Treatment
    1 52 YR