BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SOFT TISSUE BIOPSY CO-AXIAL INTRODUCER NEEDLES

    MDR report key: 650129 · Received November 30, 2005

    Report

    Report Number
    1036710-2005-00007
    Event Type
    Malfunction
    Date Received
    November 30, 2005
    Date of Event
    November 4, 2005
    Report Date
    November 30, 2005
    Manufacturer
    MEDICAL DEVICE TECHNOLOGIES, INC.
    Product Code
    DYB
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UT, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    CUSTOMER CLAIMS AN INTRODUCER NEEDLE, INTENDED TO REMAIN STATIONARY, TRAVELED FORWARD UPON FIRING THE INSTRUMENT CONTAINED WITHIN, MOVING THE MARKER AS WELL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SOFT TISSUE BIOPSY CO-AXIAL INTRODUCER NEEDLES INTRODUCER NEEDLE DYB MEDICAL DEVICE TECHNOLOGIES, INC. * 522212P7

    Patients

    Seq Age Sex Outcome Treatment
    1 *