BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RX 5000 HEARING AIDS

    MDR report key: 9636564 · Received January 27, 2020

    Report

    Report Number
    MW5092538
    Event Type
    Malfunction
    Date Received
    January 27, 2020
    Date of Event
    December 25, 2019
    Report Date
    January 23, 2020
    Manufacturer
    NANO ADVANCED HEARING TECHNOLOGY
    Product Code
    OSM
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    AL, US
    Reporter Occupation
    PATIENT FAMILY MEMBER OR FRIEND

    Narratives

    Description of Event or Problem · 1

    I BOUGHT A PAIR OF HEARING AIDS FROM THE COMPANY (B)(6) UNDER A 60 DAY RETURN POLICY. ONE OF THE HEARING AIDS WAS DEFECTIVE AND I CALLED ON (B)(6) 2019 TO RETURN THE PRODUCT. JUST UNDER THE 60 DAY TRIAL PERIOD. THEY REFUSED TO HONOR THE RETURN STATED THEY CHANGED THEIR RETURN POLICY TO 45 DAYS. I HAVE AN EMAIL ON MY ORDER AND A (B)(6) POST FROM (B)(6)STATING THE OFFER WAS ON A 60 DAY TRIAL PERIOD. THE PERSON I BOUGHT THIS FOR IS AN (B)(6) LADY WHO WAS AND STILL IS DISAPPOINTED ABOUT THIS. FDA SAFETY REPORT ID# (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    98044 RX 5000 HEARING AIDS HEARING AID, AIR CONDUCTION WITH WIRELESS TECHNOLOGY OSM NANO ADVANCED HEARING TECHNOLOGY RX5000

    Patients

    Seq Age Sex Outcome Treatment
    1 85 YR