BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TRIUMPH I PORT

    MDR report key: 36530 · Received September 4, 1996

    Report

    Report Number
    1056436-1996-00058
    Event Type
    Injury
    Date Received
    September 4, 1996
    Date of Event
    August 1, 1996
    Report Date
    September 3, 1996
    Manufacturer
    HORIZON MEDICAL PRODUCTS, INC.
    Product Code
    LJT
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MS, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    ASST. RISK MGR STATED THAT THE DEVICE WAS REMOVED (SURGICALLY EXPLANTED) BECAUSE IT DID NOT FUNCTION. NO ADD'L INFO WAS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TRIUMPH I PORT Implant VASCULAR ACCESS DEVICE LJT HORIZON MEDICAL PRODUCTS, INC. SSD-16-I NA

    Patients

    Seq Age Sex Outcome Treatment
    1 71 YR Hospitalization| O