BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SIMON NITINOL FILTER SYSTEM

    MDR report key: 3761165 · Received December 31, 2013

    Report

    Report Number
    2020394-2013-00483
    Event Type
    Injury
    Date Received
    December 31, 2013
    Date of Event
    January 4, 2005
    Report Date
    December 3, 2013
    Manufacturer
    BARD PERIPHERAL VASCULAR, INC.
    Product Code
    DTK
    PMA / PMN Number
    K970099
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    ATTORNEY

    Narratives

    Additional Manufacturer Narrative · 1

    THE LOT NUMBER HAS NOT BEEN PROVIDED, THEREFORE, THE DEVICE HISTORY RECORDS COULD NOT BE REVIEWED. THE INVESTIGATION IS CURRENTLY UNDERWAY.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT SOME TIME AFTER IMPLANTATION OF A VENA CAVA FILTER, FILTER FRACTURE WAS DISCOVERED. THERE WAS NO REPORTED PATIENT INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    682519 SIMON NITINOL FILTER SYSTEM VENA CAVA FILTER DTK BARD PERIPHERAL VASCULAR, INC. UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 52 YR Other