BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    THE CLARA HEARING AID

    MDR report key: 19804914 · Received July 22, 2024

    Report

    Report Number
    MW5157463
    Event Type
    Malfunction
    Date Received
    July 22, 2024
    Date of Event
    April 12, 2024
    Report Date
    July 16, 2024
    Manufacturer
    AUDICUS/UNITRON HEARING A DIVISION OF NATIONAL HEARING SERVICES INC.
    Product Code
    OSM
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    MO, US
    Reporter Occupation
    PATIENT
    Health Professional
    *

    Narratives

    Description of Event or Problem · 0

    HEARING AID NO LONGER WORKS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    357674 THE CLARA HEARING AID HEARING AID, AIR-CONDUCTION WITH WIRELESS TECHNOLOGY, PRESCRIPTION OSM AUDICUS/UNITRON HEARING A DIVISION OF NATIONAL HEARING SERVICES INC. AU R 315

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR Male Other ASPIRIN LOW DOSE 81 MG CHW.| EZETIMIBE 10 MG TAB. | LISINOPRIL 20 MG TAB. | LORATADINE 10 MG TAB. | METFORMIN HCL 1000MG TAB. | ROSUVASTATIN CALCIUM 40 MG TAB.