BEUDAMED
    FDA Adverse Event Injury Summary report: N

    THE DIRECT SYSTEM

    MDR report key: 416913 · Received September 17, 2002

    Report

    Report Number
    1651971-2002-00003
    Event Type
    Injury
    Date Received
    September 17, 2002
    Date of Event
    August 9, 2002
    Report Date
    September 14, 2002
    Manufacturer
    SOUNDTEC, INC.
    Product Code
    ESD
    Report Source
    Manufacturer report
    Reporter Location
    MS, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    SURGEON REPORTED THAT THE IMPLANT FOLLOWED HIS METAL INSTRUMENT DURING A MIDDLE EAR PROCEDURE AND EXPLANTED THE IMPLANT. THE SURGEON HAD NO EXPERIENCE WITH SOUNDTEC SYSTEM. THE PROCEDURE WAS UNEVENTFUL AND THE PT WAS RELEASED ON THE SAME DAY AS THE PROCEDURE. SURGEON WAS NOT THE IMPLANTING PHYSICIAN.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Other