BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VENA SEAL CLOSURE SYSTEM

    MDR report key: 5476092 · Received March 3, 2016

    Report

    Report Number
    3011410703-2016-00002
    Event Type
    Injury
    Date Received
    March 3, 2016
    Date of Event
    March 27, 2015
    Report Date
    April 7, 2015
    Manufacturer
    SAPHEON/MEDTRONIC
    Product Code
    MGO
    PMA / PMN Number
    P140018
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).  A CAPA HAS BEEN OPENED TO MANAGE THE ACTIONS RELATED TO REMEDIATION OF COMPLAINT FILES AND ANY REQUIRED MDR REPORTING. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THE PATIENT UNDERWENT VENASEAL TREATMENT OF LEFT LONG SAPHENOUS VEIN. NO PROBLEMS AT THE TIME OF THE PROCEDURE, BUT 11 DAYS LATER, PATIENT HAS CONTACTED THE DOCTOR COMPLAINING OF REDNESS ON THE SKIN, ITCH AND SOME PAIN. THE SAMPLE WAS NOT AVAILABLE FOR RETURN BY THE END USER. THE MILD INFLAMMATION RESPONDED WELL TO ORAL AND TOPICAL ANTI-INFLAMMATORY WHICH IS CONSISTENT WITH NON-SPECIFIC MILD INFLAMMATION OF THE CUTANEOUS AND SUBCUTANEOUS TISSUE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    134661 VENA SEAL CLOSURE SYSTEM CLOSURE, WOUND, ADHESIVE MGO SAPHEON/MEDTRONIC SP-101 37621

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention