BEUDAMED
    FDA Adverse Event Other Summary report: N

    VNUS CLOSURE FAST CATHETER

    MDR report key: 1014109 · Received March 12, 2008

    Report

    Report Number
    2953189-2008-00002
    Event Type
    Other
    Date Received
    March 12, 2008
    Report Date
    March 11, 2008
    Manufacturer
    NUS MEDICAL TECHNOLOGIES
    Product Code
    GEI
    PMA / PMN Number
    NA
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE CLOSUREFAST CATHETER WAS NOT RETURNED AND COULD NOT BE EVALUATED. ADDITIONAL DETAILS HAVE BEEN REQUESTED. IF ANY ADDITIONAL INFORMATION IS OBTAINED, A FOLLOW-UP REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    SUSPECTED THROMBUS EXTENSION REPORTED. PHYSICIAN REPORTED USING LOVENOX AND COUMADIN FOR TWO PATIENTS. ADDITIONAL DETAILS COULD NOT BE OBTAINED FROM THE REPORTING PHYSICIAN. UNK DATE OF EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 VNUS CLOSURE FAST CATHETER RADIO FREQUENCY CATHETER GEI NUS MEDICAL TECHNOLOGIES CF7-7-?? NA

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention