BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TRIUMPH-1 PORT

    MDR report key: 336121 · Received June 6, 2001

    Report

    Report Number
    1056436-2001-00076
    Event Type
    Injury
    Date Received
    June 6, 2001
    Date of Event
    March 23, 2001
    Report Date
    June 6, 2001
    Manufacturer
    HORIZON MEDICAL PRODUCTS, INC.
    Product Code
    LJT
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    ON 05/08/2001, THE FACILITY'S MATERIALS MGR DIRECTOR INFORMED THE MFR'S SALES REP OF THE FOLLOWING: THE OR RETURNED THE DEVICE TO THE MATERIALS MANAGEMENT DEPT WITH A NOTE THAT STATES, DEVICE DID NOT FUNCTION PROPERLY:. OR PULLED ANOTHER DEVICE FROM STOCK AND USED IT FOR THE PT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    26149 TRIUMPH-1 PORT VASCULAR ACCESS PORT LJT HORIZON MEDICAL PRODUCTS, INC. NA 1-512090B

    Patients

    Seq Age Sex Outcome Treatment
    1 72 YR Other