BEUDAMED
    FDA Adverse Event Summary report: N

    BARD PERIPHERAL VASCULAR INC.

    MDR report key: 3042795 · Received April 3, 2013

    Report

    Report Number
    MW5029654
    Date Received
    April 3, 2013
    Date of Event
    March 27, 2013
    Report Date
    April 3, 2013
    Manufacturer
    BARD PERIPHERAL VASCULAR, INC.
    Product Code
    DTK
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    FL, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    MVC TRAUMA WITH AN IVC FILTER, FRACTURE, WITH ABDOMINAL PAIN. IVC FILTER REMOVAL, INTRAVASCULAR RETRIEVAL OF A FOREIGN BODY. HISTORY OF MVC (B)(6) 2012 WITH AN IVC FILTER, FRACTURE, WITH ABDOMINAL PAIN. A KUB FROM (B)(6) 2012 REVEALED NO EVIDENCE OF A FRACTURE, AND A RECENT KUB FROM (B)(6) 2013 REVEALED A TILT OF THE AXIS OF THE FILTER WITH A FRACTURE NOTED. ON (B)(6) 2013, THE FILTER WAS REMOVED. THE PT TOLERATED THE PROCEDURE RELATIVELY WELL AND WAS DISCHARGED HOME THE SAME DAY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    136870 BARD PERIPHERAL VASCULAR INC. MEDIAN VENA CAVA FILTER DTK BARD PERIPHERAL VASCULAR, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 20 YR Required Intervention