BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HEARING AID

    MDR report key: 18622509 · Received January 31, 2024

    Report

    Report Number
    MW5150944
    Event Type
    Malfunction
    Date Received
    January 31, 2024
    Date of Event
    January 29, 2024
    Report Date
    January 29, 2024
    Manufacturer
    M D HEARING / MDHEARINGAID
    Product Code
    QUF
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    GA, US
    Reporter Occupation
    PATIENT
    Health Professional
    *

    Narratives

    Description of Event or Problem · 0

    THERE ARE SEVERAL OTC SUPPOSED HEARING AIDS WHICH ARE IN ACTUALITY JUST AMPLIFIERS. THERE IS NO WAY TO SET THEM TO THE SPECIFIC USERS FREQUENCIES WHERE THEY HAVE HEARING LOSS. THEY SHOULD NOT BE ALLOWED TO SELL THEM AS HEARING AIDS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    288922 HEARING AID HEARING AID, AIR-CONDUCTION, OVER THE COUNTER QUF M D HEARING / MDHEARINGAID NEO

    Patients

    Seq Age Sex Outcome Treatment
    1 69 YR Male TOO MANY