BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MIRACLE EAR

    MDR report key: 36368 · Received August 29, 1996

    Report

    Report Number
    MW1009841
    Event Type
    Malfunction
    Date Received
    August 29, 1996
    Report Date
    August 20, 1996
    Manufacturer
    MIRACLE-EAR/DAHLBERG, INC.
    Product Code
    ESD
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    MA, US
    Reporter Occupation
    AUDIOLOGIST

    Narratives

    Description of Event or Problem · 1

    HEARING AIDS PURCHASED DO NOT PROPERLY FIT THE EAR CANALS. THE POOR PHYSICAL FIT SIGNIFICANTLY LIMITS THE VOLUME CAPABILITY OF THE HEARING AIDS. RECASING THE HEARING AIDS SHOULD IMPROVE THE SITUATION. THIS WOULD INVOLVE TAKING NEW IMPRESSIONS OF THE EARS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MIRACLE EAR HEARING AID ESD MIRACLE-EAR/DAHLBERG, INC. CANAL AIDS *

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR