BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VENA CAVA FILTER

    MDR report key: 21366 · Received March 21, 1995

    Report

    Report Number
    21366
    Event Type
    Injury
    Date Received
    March 21, 1995
    Date of Event
    February 14, 1995
    Report Date
    March 21, 1995
    Manufacturer
    MEDI-TECH
    Product Code
    DTK
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    CA, US
    Reporter Occupation
    INVALID DATA

    Narratives

    Description of Event or Problem · 1

    DURING SURGERY FOR A DEEP VEIN THROMBOSIS, A FILTER WAS INSERTED IN THE VEIN. THE FILTER WOULD NOT OPEN AS DESIGNED AND THEREFORE COULD NOT BE SECURED FROM TRAVELLING FURTHER IN THE VEIN. SURGERY COULD NOT BE PERFORMED TO REMOVE THE FILTER DUE TO THE THREAT OF BLEEDING. A SECOND FILTER WAS INSERTED "DOWN STREAM" TO STOP THE 1ST FILTER SHOULD IT TRAVEL, AS WELL AS ANY CLOTS IN THE VEIN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 VENA CAVA FILTER FILTER DTK MEDI-TECH 50-300

    Patients

    Seq Age Sex Outcome Treatment
    1 40 YR Required Intervention