BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ARGOSY

    MDR report key: 208586 · Received February 3, 1999

    Report

    Report Number
    MW1015578
    Event Type
    Malfunction
    Date Received
    February 3, 1999
    Report Date
    February 3, 1999
    Manufacturer
    ARGOSY ELECTRONICS
    Product Code
    ESD
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    MN, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    RPTR HAS TWO HEARING AIDS WHICH HE PURCHASED 16 MONTHS AGO. SINCE THEN THEY HAVE BEEN IN THE SHOP FOR REPAIR APPROX 75% OF THE TIME. WHEN THEY WERE WORKING, HE ONLY USED THEM A MAXIMUM OF 5 HRS A DAY. THE MAIN PROBLEM WITH THEM IS NOISE OR INTERNAL FEEDBACK. MFR HAS REPLACED NUMEROUS PARTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ARGOSY HEARING AID ESD ARGOSY ELECTRONICS UNK UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 41 YR Other