BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AUDIEN ATOM

    MDR report key: 19002641 · Received March 28, 2024

    Report

    Report Number
    MW5153347
    Event Type
    Malfunction
    Date Received
    March 28, 2024
    Date of Event
    March 26, 2024
    Report Date
    March 26, 2024
    Manufacturer
    AUDIEN HEARING
    Product Code
    QUF
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    HI, US
    Reporter Occupation
    PATIENT
    Health Professional
    *

    Narratives

    Description of Event or Problem · 0

    PURCHASED OTC (OVER THE COUNTER) HEARING AIDS (B)(6) 2023. USE IT 1-2 HRS ONCE A WEEK. TODAY ONE UNIT DOES NOT WORK...FULLY RECHARGED BOTH, STILL NO CHANGE. TRIED CUSTOMER SUPPORT AT "[email protected]"...THEY WANTED MY CREDIT CARD NUMBER! REFERENCE REPORT: MW5153348.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1567105 AUDIEN ATOM HEARING AID, AIR-CONDUCTION, OVER THE COUNTER QUF AUDIEN HEARING

    Patients

    Seq Age Sex Outcome Treatment
    1 80 YR Male