BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ODE

    MDR report key: 312564 · Received January 11, 2001

    Report

    Report Number
    1416900-2000-00013
    Event Type
    Malfunction
    Date Received
    January 11, 2001
    Date of Event
    March 1, 2000
    Report Date
    March 27, 2000
    Manufacturer
    BELTONE ELECTRONICS CORP.
    Product Code
    ESD
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    THE HEARING AID (H/A) USER REPORTED THAT THE H/A BROKE OFF IN USER'S EAR CANAL WHILE TRYING TO REMOVE IT. THE DEVICE WAS EXTRACTED BY THE H/A USER'S DOCTOR. NO INJURY WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1273 ODE HEARING AID ESD BELTONE ELECTRONICS CORP. NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Required Intervention