BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ODE

    MDR report key: 262237 · Received February 11, 2000

    Report

    Report Number
    1416900-1999-00066
    Event Type
    Injury
    Date Received
    February 11, 2000
    Date of Event
    December 1, 1999
    Report Date
    December 22, 1999
    Manufacturer
    BELTONE ELECTRONICS CORP.
    Product Code
    ESD
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    THE HEARING AID (H/A) USER REPORTED PAIN IN EARS AND WAS REFERRED TO PT'S DOCTOR, WHO DIAGNOSED AN INFECTION. THE DISPENSER SENT THE AID IN TO REMAKE THE SHELL WITH HYPO ALLERGENIC MATERIAL.

    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 38 YR Required Intervention