BEUDAMED
    FDA Adverse Event Summary report: N

    EUROLINE HEARING AID

    MDR report key: 28868 · Received December 18, 1995

    Report

    Report Number
    MW1007956
    Date Received
    December 18, 1995
    Date of Event
    September 1, 1995
    Manufacturer
    STARKEY LABORATORIES,INC.
    Product Code
    ESD
    Adverse Event
    Yes
    Report Source
    Voluntary report
    Reporter Location
    CT, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    RPTR HAD BILATERAL HEARING AIDS FOR APPROX 1 MONTH BEFORE THEY STOPPED WORKING. MFR REPLACED DEVICES. SECOND SET HAS BEEN REPAIRED 3 TIMES. ON ONE OCCASION THE AMPLIFIER MALFUNCTIONED. ON 12/18/95 MFR REPLACED BOTH HEARING AIDS BECAUSE OF CONTINUED PROBLEMS. RPTR STATES HE WAS TOLD BY DISTRIBUTOR NOT TO OPEN BATTERY DOOR AT NIGHT. DOOR DOES NOT APPEAR TO BE STURDY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 EUROLINE HEARING AID HEARING AID ESD STARKEY LABORATORIES,INC. 95017649

    Patients

    Seq Age Sex Outcome Treatment
    1 *