BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ODE

    MDR report key: 178602 · Received July 22, 1998

    Report

    Report Number
    1416900-1998-00038
    Event Type
    Injury
    Date Received
    July 22, 1998
    Date of Event
    June 1, 1998
    Report Date
    June 16, 1998
    Manufacturer
    BELTONE ELECTRONICS CORP.
    Product Code
    ESD
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    THE HEARING AID (H/A) USER COMPLAINED THAT H/A FIT TOO TIGHTLY IN HIS EAR, CAUSING PAIN. THE H/A DISPENSER REFERRED THE USER TO A DOCTOR. THE DOCTOR DIAGNOSED AN INFECTION AND PRESCRIBED ANTIBIOTIC DROPS. THE INFECTION CLEARED UP. THE HEARING AID WAS REMADE AND IS FITTING COMFORTABLE NOW.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Required Intervention