BEUDAMED
    FDA Adverse Event Injury Summary report: N

    G2 FILTER SYSTEM - FEMORAL

    MDR report key: 3761202 · Received December 31, 2013

    Report

    Report Number
    2020394-2013-00467
    Event Type
    Injury
    Date Received
    December 31, 2013
    Date of Event
    December 7, 2010
    Report Date
    April 28, 2021
    Manufacturer
    BARD PERIPHERAL VASCULAR, INC.
    Product Code
    DTK
    PMA / PMN Number
    K062887
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 1

    THE LOT NUMBER FOR THE DEVICE HAS BEEN PROVIDED. A REVIEW OF THE DEVICE HISTORY RECORDS IS CURRENTLY BEING PERFORMED. THE DEVICE HAS BOT BEEN RETURNED TO THE MANUFACTURER FOR EVALUATION. THE INVESTIGATION IS CURRENTLY UNDERWAY.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT SOME TIME AFTER IMPLANTATION OF A VENA CAVA FILTER, IVC PERFORATION WAS DISCOVERED. THE FILTER REMAINS IMPLANTED. THERE WAS NO REPORTED PATIENT INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    682530 G2 FILTER SYSTEM - FEMORAL VENA CAVA FILTER DTK BARD PERIPHERAL VASCULAR, INC. GFQC3080

    Patients

    Seq Age Sex Outcome Treatment
    1 21 YR Other