BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BRAINSWAY

    MDR report key: 14470472 · Received May 20, 2022

    Report

    Report Number
    MW5109814
    Event Type
    Injury
    Date Received
    May 20, 2022
    Date of Event
    May 11, 2022
    Report Date
    May 18, 2022
    Manufacturer
    BRAINSWAY LTD.
    Product Code
    QCI
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    ID, US
    Reporter Occupation
    PATIENT
    Health Professional
    *

    Narratives

    Description of Event or Problem · 0

    I WAS GETTING BRAINSWAY TMS. HELMET WAS NOT PLACED RIGHT AND GIVING ME HEADACHES EVERY DAY ON RIGHT SIDE. FDA SAFETY REPORT ID # (B)(6).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    342486 BRAINSWAY TRANSCRANIAL MAGNETIC STIMULATION SYSTEM FOR OBSESSIVE-COMPULSIVE DISORDER QCI BRAINSWAY LTD.

    Patients

    Seq Age Sex Outcome Treatment
    1 37 YR Unknown MAGNESIUM| MULTIVITAMIN