BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    THE DIRECT SYSTEM

    MDR report key: 527583 · Received February 24, 2004

    Report

    Report Number
    1651971-2004-00001
    Event Type
    Malfunction
    Date Received
    February 24, 2004
    Date of Event
    January 20, 2004
    Report Date
    February 22, 2004
    Manufacturer
    SOUNDTEC, INC.
    Product Code
    MPV
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    SURGEON REPORTED THAT PT EXPERIENCED TYMPANIC MEMBRANE PERFORATION AND SURGEON COULD NOT ATTRIBUTE THIS EVENT TO ANY CAUSAL FACTORS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 THE DIRECT SYSTEM MIDDLE EAR IMPLANT/PROCESSOR COIL ASM MPV SOUNDTEC, INC. 300-0072-001 2-0653A

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Other