BEUDAMED
    FDA Adverse Event Other Summary report: N

    BAXTER PTFE VASCULAR GRAFT

    MDR report key: 34578 · Received July 8, 1996

    Report

    Report Number
    34578
    Event Type
    Other
    Date Received
    July 8, 1996
    Date of Event
    April 12, 1996
    Report Date
    April 16, 1996
    Manufacturer
    EDWARDS CVS DIV. BAXTER HEALTHCARE CORP.
    Product Code
    DSY
    Adverse Event
    Yes
    Report Source
    User Facility report
    Reporter Location
    MA, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    A SECTION OF THE 6MM PTFE GRAFT MATERIAL WAS IMPLANTED IN THE RIGHT FEMORAL POPLITEAL ARTERY. THE NEEDLE HOLES IN THE GRAFT CONTINUED TO OOZE BLOOD 1 HR POST ANASTOMOSIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BAXTER PTFE VASCULAR GRAFT PTFE VASCULAR GRAFT DSY EDWARDS CVS DIV. BAXTER HEALTHCARE CORP. T06080C80/6MM NA

    Patients

    Seq Age Sex Outcome Treatment
    1 84 YR Other