BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ODE

    MDR report key: 321081 · Received March 15, 2001

    Report

    Report Number
    1416900-2000-00143
    Event Type
    Injury
    Date Received
    March 15, 2001
    Date of Event
    March 1, 2000
    Report Date
    March 2, 2000
    Manufacturer
    BELTONE ELECTRONICS CORP.
    Product Code
    ESD
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    THE HEARING AID (H/A) DISPENSER REPORTED THAT THE USER DEVELOPED A SORE SPOT, ATTRIBUTED TO WEARING THE HEARING AID, THAT BECAME INFECTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    11900 ODE HEARING AID ESD BELTONE ELECTRONICS CORP. NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 40 YR Required Intervention