BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ODE

    MDR report key: 158152 · Received March 13, 1998

    Report

    Report Number
    1416900-1998-00013
    Event Type
    Malfunction
    Date Received
    March 13, 1998
    Date of Event
    February 1, 1998
    Report Date
    February 19, 1998
    Manufacturer
    BELTONE ELECTRONICS CORP.
    Product Code
    ESD
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CT, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    THE DISPENSER NOTICED A WAX GUARD EMBEDDED IN THE EAR WAX DURING A ROUTINE CHECKUP. HE REFERRED THE USER TO A DOCTOR FOR REMOVAL. THE DISPENSER THEN PUT A SECOND WAX GUARD ON THE AID. LATER THE DISPENSER NOTICED THE WAX GUARD WAS MISSING, AND FOUND IT IN THE USER'S EAR. HE WAS ABLE TO REMOVE IT WITH NO FURTHER PROBLEMS -- NO REDNESS, NO SWELLING, OR NO PAIN.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR Required Intervention