BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ODE

    MDR report key: 173351 · Received June 19, 1998

    Report

    Report Number
    1416900-1998-00036
    Event Type
    Injury
    Date Received
    June 19, 1998
    Date of Event
    May 1, 1998
    Report Date
    May 22, 1998
    Manufacturer
    BELTONE ELECTRONICS CORP.
    Product Code
    ESD
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SC, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    THE CLIENT HAS HAD A HISTORY OF EAR INFECTIONS WHICH ALWAYS SEEM TO WORSEN WHEN SHE WEARS A HEARING AID. HER 1992 HEARING AID WAS REMADE USING CO'S NEW HYPO-ALLERGENIC SHELL PROCESS. SHE IS CURRENTLY UNDER A DR'S CARE.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 74 YR Required Intervention