BEUDAMED
    FDA Adverse Event Other Summary report: N

    OPTIMA 2000

    MDR report key: 339898 · Received June 29, 2001

    Report

    Report Number
    1416900-2001-00051
    Event Type
    Other
    Date Received
    June 29, 2001
    Date of Event
    May 1, 2001
    Report Date
    June 22, 2001
    Manufacturer
    BELTONE ELECTRONICS CRP.
    Product Code
    ESD
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    THE HEARING AID (H/A) DISPENSER REPORTED THAT THE HEARING AID USER HAD DEVELOPED AN EAR INFECTION AS A RESULT OF A POORLY FITTING DEVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    29729 OPTIMA 2000 HEARING AID ESD BELTONE ELECTRONICS CRP. NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Required Intervention