BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ODE

    MDR report key: 317776 · Received February 23, 2001

    Report

    Report Number
    1416900-2000-00028
    Event Type
    Malfunction
    Date Received
    February 23, 2001
    Date of Event
    June 1, 2000
    Report Date
    June 12, 2000
    Manufacturer
    BELTONE ELECTRONICS CORP.
    Product Code
    ESD
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KY, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    THE HEARING AID (H/A) USER REPORTED THAT THE WAXGUARD CAME UNSEATED WHILE THE H/A WAS WORN IN THEIR EAR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    7398 ODE HEARING AID ESD BELTONE ELECTRONICS CORP. NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN