BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TRIUMPH-1 PORT

    MDR report key: 319250 · Received March 8, 2001

    Report

    Report Number
    1056436-2001-00024
    Event Type
    Injury
    Date Received
    March 8, 2001
    Date of Event
    January 10, 2001
    Report Date
    March 8, 2001
    Manufacturer
    HORIZON MEDICAL PRODUCTS, INC.
    Product Code
    LJT
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    PATIENT FAMILY MEMBER OR FRIEND

    Narratives

    Description of Event or Problem · 1

    ON 02/16/2001, THE PT'S SPOUSE INFORMED THE MFR'S REP OF THE FOLLOWING: SPOUSE HAS CANCER AND HAD A VASCULAR ACCESS DEVICE IMPLANTED AND DEVELOPED A STAPH INFECTION AND THE DEVICE HAD TO BE REMOVED. SPOUSE STATED THE DEVICE WAS LEFT AT THE HOSP. NO FURTHER DETAILS ARE AVAILABLE AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    9943 TRIUMPH-1 PORT VASCULAR ACCESS DEVICE-PORT LJT HORIZON MEDICAL PRODUCTS, INC. NA 4-511090D

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Required Intervention