BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FLIXENE GW AND GWT GRAFTS > OR = 6MM

    MDR report key: 3931780 · Received June 24, 2014

    Report

    Report Number
    1219977-2014-00191
    Event Type
    Injury
    Date Received
    June 24, 2014
    Date of Event
    May 22, 2014
    Report Date
    May 26, 2014
    Manufacturer
    ATRIUM MEDICAL CORP.
    Product Code
    DSY
    PMA / PMN Number
    K071923
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    ME, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    UPON COMPLETION OF THE INVESTIGATION INTO THIS EVENT A FOLLOW UP REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    PATIENT RECEIVED A GRAFT FOR DIALYSIS. IMPLANTATION OF GRAFT OCCURRED WITHOUT ISSUE. POST IMPLANTATION, THE PATIENT WAS EXPERIENCING A SWOLLEN ARM WITH ERYTHEMA IN THE U PATTERN OF THE GRAFT WHICH IMPROVED IN A FEW DAYS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    369406 FLIXENE GW AND GWT GRAFTS > OR = 6MM PROSTHESIS VASCULAR GRAFT DSY ATRIUM MEDICAL CORP. 25137 200377

    Patients

    Seq Age Sex Outcome Treatment
    1 58 YR Required Intervention