BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FLIXENE GRAFTS

    MDR report key: 4121159 · Received September 24, 2014

    Report

    Report Number
    1219977-2014-00313
    Event Type
    Injury
    Date Received
    September 24, 2014
    Date of Event
    August 21, 2014
    Report Date
    September 1, 2014
    Manufacturer
    ATRIUM MEDICAL CORP.
    Product Code
    DSY
    PMA / PMN Number
    K060124
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SF
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    WE ARE IN THE PROCESS OF PERFORMING THE INVESTIGATION AND WILL SUBMIT THE FOLLOW-UP REPORT ONCE THE EVALUATION IS COMPLETED.

    Description of Event or Problem · 1

    GRAFT WAS IMPLANTED AND DIALYSIS WAS COMPLETED AFTER 24 HOURS WITHOUT ISSUE. A FEW DAYS LATER, THE PATIENTS ARM BECAME RED, BLOTCHY AND SWOLLEN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    594756 FLIXENE GRAFTS PROSTHESIS, VASCULAR GRAFT DSY ATRIUM MEDICAL CORP.

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention