BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CLOSURE CATHETER

    MDR report key: 380827 · Received March 8, 2002

    Report

    Report Number
    2953189-2002-00003
    Event Type
    Injury
    Date Received
    March 8, 2002
    Date of Event
    January 9, 2002
    Report Date
    March 7, 2002
    Manufacturer
    VNUS MEDICAL TECHNOLOGIES, INC.
    Product Code
    DQO
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    IN 2002 DURING THE F/U, APPROXIMATELY 20 CM THROMBUS WAS DETECTED IN THE TREATED LEFT LIMB USING DUPLEX ULTRASOUND. FURTHER DETAILS OF THE NATURE AND LOCATION OF THE THROMBUS OR SYMPTOMS IS NOT AVAILABLE. THE PT WAS HOSPITALIZED FOR AN UNSPECIFIED AMOUNT OF TIME AND PLACED ON THROMBOLYTIC AND ANTICOAGULATION (COUMADIN) THERAPY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CLOSURE CATHETER INTRAVASCULAR CATHETER DQO VNUS MEDICAL TECHNOLOGIES, INC. UNK UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 21 YR Hospitalization