BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    THE DIRECT SYSTEM

    MDR report key: 366720 · Received December 18, 2001

    Report

    Report Number
    1651971-2001-00001
    Event Type
    Malfunction
    Date Received
    December 18, 2001
    Date of Event
    November 15, 2001
    Report Date
    December 7, 2001
    Manufacturer
    SOUNDTEC, INC.
    Product Code
    MPV
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    SURGEON REPORTS THAT THE IMPLANT MAY HAVE BEEN PLACED IN AN ORIENTATION INCONSISTENT WITH THE SURGEON'S MANUAL INSTRUCTIONS FOR USE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    57186 THE DIRECT SYSTEM MIDDLE EAR IMPLANT MPV SOUNDTEC, INC. 300-0039-001 1356

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR Other