BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VENA SEAL CLOSURE SYSTEM

    MDR report key: 6060709 · Received October 27, 2016

    Report

    Report Number
    3011410703-2016-00020
    Event Type
    Injury
    Date Received
    October 27, 2016
    Date of Event
    September 8, 2016
    Report Date
    September 30, 2016
    Manufacturer
    MORRISVILLE
    Product Code
    PJQ
    PMA / PMN Number
    P140018
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    A GOOD FAITH EFFORT WILL BE MADE TO OBTAIN THE APPLICABLE INFORMATION RELEVANT TO THE REPORT. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Additional Manufacturer Narrative · 1

    IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    PHYSICIAN USED A VENA SEAL DEVICE TO TREAT PATIENT AT THE BILATERAL GREAT SAPHENOUS VEIN. NO ISSUES NOTED DURING PROCEDURE. PATIENT COMPLAINED OF REDNESS/RASH ALONG THE TREATED VEINS ON BOTH LIMBS AFTER THE PROCEDURE. THE PATIENT ALSO COMPLAINED OF HAVING FEVER/CHILLS THREE DAYS AFTER THE PROCEDURE. THE PATIENT WAS SEEN THE FOLLOWING MONDAY AND WAS GIVEN NSAIDS AND ANTIBIOTICS DUE TO THE FEVER AND CHILLS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    711844 VENA SEAL CLOSURE SYSTEM AGENT, OCCLUDING, VASCULAR, PERMANENT PJQ MORRISVILLE

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention