BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ODE

    MDR report key: 144468 · Received January 16, 1998

    Report

    Report Number
    1416900-1997-00047
    Event Type
    Injury
    Date Received
    January 16, 1998
    Date of Event
    December 1, 1997
    Report Date
    December 15, 1997
    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) DISPENSER NOTICED SORENESS IN THE USER'S EAR CANAL AND ADVISED THE USER NOT TO WEAR THE HEARING AID FOR A FEW DAYS. USER INSISTED ON WEARING THE HEARING AID, AND A LOCALIZED INFECTION (INFECTED SORE SPOT) DEVELOPED. DISPENSER REFERRED USER TO A PHYSICIAN WHO IS TREATING THE EAR WITH A PRESCRIBED OINTMENT.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR Required Intervention