BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    IPSIHAND

    MDR report key: 18518096 · Received January 12, 2024

    Report

    Report Number
    MW5150210
    Event Type
    Malfunction
    Date Received
    January 12, 2024
    Date of Event
    May 8, 2023
    Report Date
    January 9, 2024
    Manufacturer
    NEUROLUTIONS, INC.
    Product Code
    QOL
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    NY, US
    Reporter Occupation
    PATIENT
    Health Professional
    *

    Narratives

    Description of Event or Problem · 0

    I PURCHASED A PRODUCT APPROVED BY THE FDA BUT IT DIDN'T WORK AND NOW THEY WON'T GIVE ME MY PRODUCT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    639272 IPSIHAND ELECTROENCEPHALOGRAPHY (EEG)-DRIVEN UPPER EXTREMITY POWERED EXERCISER QOL NEUROLUTIONS, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 44 YR Female Other