BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ODE

    MDR report key: 121890 · Received September 17, 1997

    Report

    Report Number
    1416900-1997-00013
    Event Type
    Malfunction
    Date Received
    September 17, 1997
    Date of Event
    April 9, 1997
    Report Date
    April 9, 1997
    Manufacturer
    BELTONE ELECTRONICS CORP.
    Product Code
    ESD
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    THE HEARING AID USER CAME INTO THE DISPENSER'S OFFICE. DISPENSER FOUND A WAX GUARD FROM HER HEARING AID HAD BECOME SEPARATED FROM THE AID AND LODGED IN THE USER'S EAR CANAL. THE DISPENSER REFERRED THE USER TO AN ENT DOCTOR TO REMOVE THE WAX GUARD. THE ENT REMOVED THE WAX GUARD WITH NO FURTHER PROBLEM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ODE ITC HEARING AID ESD BELTONE ELECTRONICS CORP. NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 77 YR Required Intervention