BEUDAMED
    FDA Adverse Event Injury Summary report: N

    COOK

    MDR report key: 346499 · Received August 9, 2001

    Report

    Report Number
    346499
    Event Type
    Injury
    Date Received
    August 9, 2001
    Date of Event
    July 18, 2001
    Report Date
    August 7, 2001
    Manufacturer
    COOK, INC.
    Product Code
    LJT
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    PA, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    ADD'L INFO REC'D FROM MFR 09/17/01: ON SEPTEMBER 14, 2001, AMEDWATCH REPORT WAS RECEIVED FROM HOSPITAL CONCERNING A MINI VITAL PORT. A REVIEW OF THIS INFO REVEALED THIS PARTICULAR PRODUCT IS NOT MANUFACTURED BY COOK INC, BUT ITIS INSTEAD MANUFACTURED BY COOK VASCULAR CORP. THE ORIGINAL REPORT HAS BEEN FORWARDED TO COOK VASCULAR FOR THEIR HANDLING.

    Description of Event or Problem · 1

    INITIAL PORT PLACED IN 2000 IN THE RIGHT BASILIC VEIN FOR LONG TERM USE OF ANTICOAGULANTS AND CHEMOTHERAPY. PT UNDERWENT CARDIOVASCULAR INTERVENTIONAL RADIOLOGY (CVIR) PROCEDURE FOR LEAKAGE AROUND THE VENOUS PORT. A PARTIAL INFUSION CATHETER FRACTURE 1CM CENTRAL TO THE PORT WAS LOCATED, AND THE PT UNDERWENT REMOVAL OF THE VENOUS PORT DURING THE CVIR PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    36066 COOK MINI VITAL PORT LJT COOK, INC. 5116 *

    Patients

    Seq Age Sex Outcome Treatment
    1 74 YR Required Intervention