BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TEMNO

    MDR report key: 5077228 · Received September 15, 2015

    Report

    Report Number
    5077228
    Event Type
    Malfunction
    Date Received
    September 15, 2015
    Date of Event
    August 26, 2015
    Report Date
    August 28, 2015
    Manufacturer
    CAREFUSION 2200, INC
    Product Code
    KNW
    Adverse Event
    Yes
    Report Source
    User Facility report
    Reporter Location
    RI, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    DURING A CT BIOPSY, THE BIOPSY GUN (TEMNO) MALFUNCTIONED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    609292 TEMNO BIOPSY NEEDLE KNW CAREFUSION 2200, INC ACT2011 0000765780

    Patients

    Seq Age Sex Outcome Treatment
    1 80 YR