BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FLIXENE GRAFTS

    MDR report key: 4121158 · Received September 24, 2014

    Report

    Report Number
    1219977-2014-00314
    Event Type
    Injury
    Date Received
    September 24, 2014
    Date of Event
    April 14, 2014
    Report Date
    August 31, 2014
    Manufacturer
    ATRIUM MEDICAL CORP.
    Product Code
    DSY
    PMA / PMN Number
    K060124
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN
    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. (B)(4).

    Description of Event or Problem · 1

    THE GRAFT WAS CANNULATED WITHIN 24-48 HOURS OF IMPLANTATION. THE PATIENT PRESENTED WITH BLEEDING AT THE ANASTOMOSIS SITE (VESSEL-GRAFT CONNECTION)

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    595053 FLIXENE GRAFTS PROSTHESIS, VASCULAR GRAFT DSY ATRIUM MEDICAL CORP.

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention