BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ODE

    MDR report key: 184486 · Received August 28, 1998

    Report

    Report Number
    1416900-1998-00047
    Event Type
    Injury
    Date Received
    August 28, 1998
    Date of Event
    August 1, 1998
    Report Date
    August 14, 1998
    Manufacturer
    BELTONE ELECTRONICS CORP.
    Product Code
    ESD
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    THE HEARING AID USER COMPLAINED OF SORENESS IN EAR CANAL WHEN WEARING THE HEARING AID. THE HEARING AID SPECIALIST EXAMINED THE EAR AND SAID IT WAS RED AND INFLAMED. THE HEARING AID USER WAS REFERRED TO A DR WHO PRESCRIBED MEDICATION AND ADVISED HIM NOT TO WEAR A HEARING AID IN THE EAR UNTIL IT HAD A CHANCE TO HEAL.

    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 UNKNOWN Required Intervention