BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BAXTER LIFESPAN EPTFE VASCULAR GRAFT

    MDR report key: 234840 · Received August 4, 1999

    Report

    Report Number
    6000002-1999-00219
    Event Type
    Injury
    Date Received
    August 4, 1999
    Date of Event
    February 22, 1999
    Report Date
    July 8, 1999
    Manufacturer
    BAXTER HEALTHCARE CORP.
    Product Code
    DSY
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    THIS EVENT WAS REPORTED AS SURGICAL INTERVENTION ON 02/22/1999, 02/23/1999, AND 03/25/1999 DUE TO CLOTTING. THE DEVICE REMAINED IMPLANTED. HOWEVER, ON 04/26/1999, THIS DEVICE WAS EXPLANTED DUE TO CLOTTING. NO FURTHER INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BAXTER LIFESPAN EPTFE VASCULAR GRAFT Implant VASCULAR GRAFT DSY BAXTER HEALTHCARE CORP. R06020 6H0940

    Patients

    Seq Age Sex Outcome Treatment
    1 46 YR Required Intervention