BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CRUX VENA CAVA FILTER SYSTEM

    MDR report key: 5087382 · Received September 18, 2015

    Report

    Report Number
    2939520-2014-00100
    Event Type
    Malfunction
    Date Received
    September 18, 2015
    Date of Event
    October 27, 2014
    Report Date
    October 27, 2014
    Manufacturer
    VOLCANO CORPORATION
    Product Code
    DTK
    PMA / PMN Number
    K122585
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KY, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    620654 CRUX VENA CAVA FILTER SYSTEM FILTER, INTRAVASCULAR, CARDIOVASCULAR DTK VOLCANO CORPORATION 7024 UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown