BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NOVA LITE OTC HEARING AID

    MDR report key: 18543936 · Received January 18, 2024

    Report

    Report Number
    MW5150535
    Event Type
    Malfunction
    Date Received
    January 18, 2024
    Date of Event
    January 1, 2024
    Report Date
    January 18, 2024
    Manufacturer
    LINNER
    Product Code
    QUG
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    PA, US
    Reporter Occupation
    PATIENT FAMILY MEMBER OR FRIEND
    Health Professional
    *

    Narratives

    Description of Event or Problem · 0

    REPORTER CALLING, STATING HER MOTHER PURCHASED ONE LINNER NOVA LITE OTC (OVER THE COUNTER) HEARING AID IN (B)(6) 2023. REPORTER STATES THAT ON APPROXIMATELY (B)(6) 2024, DURING USE, THE HEARING AID BROKE APART COMPLETELY AND ALTHOUGH DID NOT GET STUCK IN HER MOTHER'S EAR, REPORTER STATES IT EASILY COULD HAVE. REPORTER EXPRESSES HER CONCERN ABOUT THE "FLIMSY DESIGN" OF THE HEARING AID AND IT BREAKING SO EASILY. REPORTER STATES SHE IS PLANNING ON CALLING LINNER, BUT HAS NOT YET DONE SO.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1774190 NOVA LITE OTC HEARING AID HEARING AID, AIR-CONDUCTION WITH WIRELESS TECHNOLOGY, OVER THE COUNTER QUG LINNER

    Patients

    Seq Age Sex Outcome Treatment
    1 97 YR Female