BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DISTAFLO BYPASS GRAFT

    MDR report key: 260301 · Received January 28, 2000

    Report

    Report Number
    2020394-1999-00020
    Event Type
    Injury
    Date Received
    January 28, 2000
    Date of Event
    November 13, 1999
    Report Date
    January 20, 2000
    Manufacturer
    IMPRA, A SUBSIDIARY OF C. R. BARD, INC.
    Product Code
    DSY
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    THE FOLLOWING INFO WAS REORTED TO IMPRA ON 12-23-1999. A FEMORAL-POPLITEAL BYPASS GRAFT WAS SUCCESSFULLY IMPLANTED IN THE PT'S RIGHT LEG IN 1999, AND IN THE LEFT LEG IN 1999. A BILATERAL FEMORAL-POPLITEAL TIBIAL THROMBECTOMY WAS PERFORMED ON 11-13-1999. A THROMBECTOMY ON THE RIGHT LEG WAS DONE ON 11-16-1999. A BILATERAL FEMORAL THROMBECTOMY WAS PERFORMED ON 12-13-1999. THE GRAFT REMAINS PATENT IN THE PT. NOTE: THIS REPORT LISTS PRODUCT INFO FOR THE GRAFT IN THE RIGHT LEG. SEE MFR. REPORT #2020394-1999-00021 FOR PRODUCT INFO ON GRAFT IN LEFT LEG.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 DISTAFLO BYPASS GRAFT VASCULAR GRAFT DSY IMPRA, A SUBSIDIARY OF C. R. BARD, INC. * *

    Patients

    Seq Age Sex Outcome Treatment
    1 52 YR Required Intervention