BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ODE

    MDR report key: 118085 · Received September 2, 1997

    Report

    Report Number
    1416900-1997-00007
    Event Type
    Malfunction
    Date Received
    September 2, 1997
    Date of Event
    September 1, 1996
    Report Date
    September 27, 1996
    Manufacturer
    BELTONE ELECTRONICS CORP.
    Product Code
    ESD
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    THE HEARING AID USER CAME TO THE DISPENSER'S OFFICE. THE DISPENSER FOUND 4 SENTRY II WAX GUARDS IN THE USER'S EAR CANAL. HE WAS ABLE TO REMOVE 2 OF THEM. HE REFERRED THE USER TO A PHYSICIAN TO REMOVE THE OTHER 2.

    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 UNKNOWN Required Intervention