BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LGM VENA CAVA FILTER

    MDR report key: 29682 · Received February 5, 1996

    Report

    Report Number
    MW1008262
    Event Type
    Injury
    Date Received
    February 5, 1996
    Date of Event
    January 16, 1996
    Report Date
    January 26, 1996
    Manufacturer
    B BRAUN VENA-TECH
    Product Code
    DTK
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    TN, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    VENA CAVA FILTER INSERTED INTO PT FAILED TO DEPLOY. A SECOND FILTER WAS INSERTED AND THIS ONE DEPLOYED PROPERLY. WHEN THE SURGEON ATTEMPTED TO REMOVE THE FIRST ONE, IT DEPLOYED. A PORTION OF IT COULD NOT BE REMOVED. NO ADDITIONAL SURGERY WAS NEEDED, AND THERE WAS NO INJURY TO THE PT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LGM VENA CAVA FILTER Implant VENA CAVA FILTER DTK B BRAUN VENA-TECH

    Patients

    Seq Age Sex Outcome Treatment
    1 77 YR Required Intervention