BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TRU-CORE II BIOPSY INSTRUMENT

    MDR report key: 611608 · Received July 6, 2004

    Report

    Report Number
    1036710-2004-00002
    Event Type
    Malfunction
    Date Received
    July 6, 2004
    Report Date
    July 6, 2004
    Manufacturer
    MEDICAL DEVICE TECHNOLOGIES, INC.
    Product Code
    KNW
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    THE STYLET SEPARATED FROM THE UNIT AFTER THE EIGHTH BIOPSY AND WAS MANUALLY REMOVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TRU-CORE II BIOPSY INSTRUMENT SOFT TISSUE BIOPSY DEVICE KNW MEDICAL DEVICE TECHNOLOGIES, INC. * 32580NAT

    Patients

    Seq Age Sex Outcome Treatment
    1 *