BEUDAMED
    FDA Adverse Event Injury Summary report: N

    THE DIRECT SYSTEM

    MDR report key: 415092 · Received September 6, 2002

    Report

    Report Number
    1651971-2002-00002
    Event Type
    Injury
    Date Received
    September 6, 2002
    Date of Event
    July 24, 2002
    Report Date
    September 5, 2002
    Manufacturer
    SOUNDTEC, INC.
    Product Code
    ESD
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    AUDIOLOGIST

    Narratives

    Description of Event or Problem · 1

    SURGEON REPORTS THAT A RIGHT IMPLANT WAS PLACED INTO THE LEFT EAR. IMPLANT WAS UNEVENTFUL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 THE DIRECT SYSTEM MIDDLE EAR IMPLANT ESD SOUNDTEC, INC. 300-0038-001 1356

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Other