BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TRIUMPH-1 VASCULAR ACCESS SYSTEM

    MDR report key: 50980 · Received July 8, 1996

    Report

    Report Number
    50980
    Event Type
    Injury
    Date Received
    July 8, 1996
    Date of Event
    February 12, 1996
    Report Date
    February 14, 1996
    Manufacturer
    HORIZON MEDICAL PRODUCTS, INC.
    Product Code
    DQO
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    OK, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    PT CXR 2/12/96 SHOWED CATHETER NOT INTACT. PT WAS ADMITTED TO HOSP, TRANSFERED TO ANOTHER FACILITY FOR CATHETER REMOVAL, AND RETURNED TO FACILITY WITH NO APPARENT COMPLICATIONS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TRIUMPH-1 VASCULAR ACCESS SYSTEM Implant DOUBLE LUMEN VASCULAR ACCESS DEVICE DQO HORIZON MEDICAL PRODUCTS, INC. * *

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR Hospitalization| L| O