BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ODE

    MDR report key: 257846 · Received January 7, 2000

    Report

    Report Number
    1416900-1999-00063
    Event Type
    Injury
    Date Received
    January 7, 2000
    Date of Event
    November 1, 1999
    Report Date
    December 2, 1999
    Manufacturer
    BELTONE ELECTRONICS CORP.
    Product Code
    ESD
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    THE HEARING AID (H/A) USER HAS A HISTORY OF EAR INFECTIONS. HE REPORTED TO THE H/A DISPENSER THAT HE HAD RECENTLY BEEN TREATED FOR A RECURRING INFECTION IN THE EAR CANAL. HE STATED THAT THE INFECTION HAD CLEARED UP, AND HIS DR HAD GIVEN HIS OK TO RESUME WEARING THE H/A AGAIN.

    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 74 YR Required Intervention