BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OPTIMA 2000

    MDR report key: 321096 · Received March 15, 2001

    Report

    Report Number
    1416900-2000-00139
    Event Type
    Injury
    Date Received
    March 15, 2001
    Date of Event
    February 1, 2000
    Report Date
    February 14, 2000
    Manufacturer
    BELTONE ELECTRONICS CORP.
    Product Code
    ESD
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    LA, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    THE HEARING AID (H/A) DISPENSER REPORTED THE USER HAS A HISTORY OF EAR INFECTIONS WHENEVER THE USER WEARS HEARING AIDS. THE USER'S PHYSICIAN ADVISED USER TO ONLY WEAR BEHIND-THE-EAR (BTE) HEARING AID BECAUSE OF PREVIOUS INFECTIONS. AGAINST THE PHYSICIAN'S ADVICE, THE USER INSISTED ON TRYING IN-THE-EAR (ITE) HEARING AIDS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    11679 OPTIMA 2000 HEARING AID ESD BELTONE ELECTRONICS CORP. NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 84 YR Required Intervention