BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LIFEPORT VASCULAR ACCESS SYSTEM

    MDR report key: 207631 · Received May 5, 1998

    Report

    Report Number
    207631
    Event Type
    Injury
    Date Received
    May 5, 1998
    Date of Event
    March 30, 1998
    Report Date
    April 24, 1998
    Manufacturer
    HORIZON MEDICAL PRODUCTS, INC.
    Product Code
    LJT
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    MO, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    PT SEEN IN ONCOLOGY CLINIC ON 3/30, PORTOCATH LEAKING AND NOT WORKING. 4/24 PT TO HOSP FOR REMOVAL OF PORTOCATH AS OUTPATIENT (& REPLACEMENT). 4/24 PT ADMITTED TO INTENSIVE CARE UNIT POST OP WITH CHEST PAIN. 4/25 TRANSFERRED TO FLOOR. 4/25, 1818 DISCHARGED HOME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LIFEPORT VASCULAR ACCESS SYSTEM Implant PORTOCATH LJT HORIZON MEDICAL PRODUCTS, INC. * 14221

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR Hospitalization| O