BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIFEPORT VASCULAR ACCESS SYSTEM

    MDR report key: 517465 · Received February 3, 2004

    Report

    Report Number
    1056436-2004-00002
    Event Type
    Malfunction
    Date Received
    February 3, 2004
    Date of Event
    December 31, 2003
    Report Date
    February 3, 2004
    Manufacturer
    HORIZON MEDICAL PRODUCTS, INC.
    Product Code
    LJT
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IA, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    IN 01/2004, THE USER FACILITY INFORMED THE MANUFACTURER'S SALES REP OF THE FOLLOWING: PORT WAS USED SEVERAL TIMES BEFORE IT STARTED TO LEAK, AROUND 20 DAYS AFTER IMPLANT, THROUGH INCISIONAL SITE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LIFEPORT VASCULAR ACCESS SYSTEM VASCULAR ACCESS PORT LJT HORIZON MEDICAL PRODUCTS, INC. NA 19397

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR