BEUDAMED
    FDA Adverse Event Other Summary report: N

    5.0FR URETHANE UMB CATH

    MDR report key: 513132 · Received February 27, 2004

    Report

    Report Number
    1314426-2004-00004
    Event Type
    Other
    Date Received
    February 27, 2004
    Date of Event
    November 15, 2002
    Report Date
    February 25, 2004
    Manufacturer
    TYCO HEALTHCARE/KENDALL
    Product Code
    FOS
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED TO TYCO HEALTHCARE/KENDALL IN 2004 THAT A CUSTOMER HAD A PROBLEM WITH A UVC CATHETER IN 2002. THE CUSTOMER REPORTS THAT DUE TO A THROMBOTIC COMPLICATION, THE PT HAD TO HAVE A FOOT AMPUTATED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 5.0FR URETHANE UMB CATH UMBILICAL VESSEL CATHETER FOS TYCO HEALTHCARE/KENDALL * UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 * Required Intervention