BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LIFEPORT LVTX - VASCULAR ACCESS SYSTEM

    MDR report key: 843579 · Received April 25, 2007

    Report

    Report Number
    MW1042722
    Event Type
    Injury
    Date Received
    April 25, 2007
    Date of Event
    February 15, 2007
    Report Date
    April 25, 2007
    Manufacturer
    ANTIOGYNAMICS, INC
    Product Code
    LJT
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    FL, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    A LIFEPORT VASCULAR ACCESS PORT CATALOG # LVTX - 7513 FROM RITA LOT #28233 MEDICAL SYSTEMS/ANGIO DYNAMICS INC WAS IMPLANTED IN 2006. CHEST X-RAY AFTER PROCEDURE SHOWED SATISFACTORY POSITIONING AND NO PNEUMOTHORAX. THE PT WAS UNDERGOING CHEMOTHERAPY FOR LYMPHOMA. WHEN INABILITY TO ACCESS THE PORT WAS REPORTED AN X-RAY WAS DONE AND REVEALED THE CATHETER WAS SPLIT UNDERNEATH THE COLLAR BONE. THE PORT WAS REMOVED IN 2007 AND REPLACED WITH A PORT FROM LOT #29207.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LIFEPORT LVTX - VASCULAR ACCESS SYSTEM VITAPORT LJT ANTIOGYNAMICS, INC * 28233

    Patients

    Seq Age Sex Outcome Treatment
    1 44 YR Disability