BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TITANPORT

    MDR report key: 349744 · Received September 4, 2001

    Report

    Report Number
    1056436-2001-00113
    Event Type
    Injury
    Date Received
    September 4, 2001
    Date of Event
    August 3, 2001
    Report Date
    September 4, 2001
    Manufacturer
    HORIZON MEDICAL PRODUCTS, INC.
    Product Code
    LJT
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    INVALID DATA

    Narratives

    Description of Event or Problem · 1

    ON 08/2001, THE USER FACILITY'S CLINICAL ENGINEER INFORMED THE MFR'S REP OF THE FOLLOWING: PT REQUIRED JUGULAR CUTDOWN TO REMOVE CUT DEVICE CATHETER OR FAULTY DEVICE. USER FACILITY STATES DEVICE WAS STERILIZED AFTER IMPLANTATION AND WILL BE RETURNED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    39959 TITANPORT VASCULAR ACCESS DEVICE LJT HORIZON MEDICAL PRODUCTS, INC. NA 980201

    Patients

    Seq Age Sex Outcome Treatment
    1 58 YR