BEUDAMED
    FDA Adverse Event Injury Summary report: N

    STARKEY MUSE RIC

    MDR report key: 8802910 · Received July 17, 2019

    Report

    Report Number
    MW5088203
    Event Type
    Injury
    Date Received
    July 17, 2019
    Date of Event
    August 7, 2018
    Report Date
    July 17, 2019
    Manufacturer
    STARKEY LABORATORIES INC.
    Product Code
    ESD
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    PA, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    PT CALLED TO REPORT PROBLEMS WITH STARKEY HEARING AIDS. PT STATED HE'S HAD PROBLEMS WITH THEM EVER SINCE HE FIRST GOT THEM ON (B)(6) 2018. PT SAYS HE'S BEEN BACK 14 TIMES FOR ADJUSTMENTS, BUT STILL CANNOT HEAR OUT OF THE RIGHT EAR, AND HAS PROBLEMS HEARING WITH THE LEFT SIDE AS WELL. PT IS FRUSTRATED WITH PRACTITIONER AND DEVICES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    590511 STARKEY MUSE RIC HEARING AID, AIR CONDUCTION ESD STARKEY LABORATORIES INC. MUSERIC
    590512 STARKEY MUSE RIC HEARING AID, AIR CONDUCTION ESD STARKEY LABORATORIES INC. MUSERIC

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR Other