BEUDAMED
    FDA Adverse Event Injury Summary report: N

    THE DIRECT SYSTEM

    MDR report key: 502451 · Received December 22, 2003

    Report

    Report Number
    1651971-2003-00002
    Event Type
    Injury
    Date Received
    December 22, 2003
    Date of Event
    November 25, 2003
    Report Date
    December 22, 2003
    Manufacturer
    SOUNDTEC, INC.
    Product Code
    ESD
    Report Source
    Manufacturer report
    Reporter Location
    AR, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    SURGEON REPORTED THAT THE IMPLANT WAS REMOVED AT THE REQUEST OF THE SUBJECT. PT FAILED TO HEED WARNINGS TO AVOID REMAINING TOO CLOSE TO DEVICES WITH HIGH MAGNETIC FIELDS SUCH AS ARCH WELDERS.

    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