BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GORE AXILLARY POPLITEAL GRAFT

    MDR report key: 15113 · Received January 14, 1994

    Report

    Report Number
    15113
    Event Type
    Injury
    Date Received
    January 14, 1994
    Date of Event
    December 15, 1993
    Report Date
    December 26, 1993
    Manufacturer
    GORE AND ASSOCIATES
    Product Code
    DSY
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    OH, US
    Reporter Occupation
    INVALID DATA

    Narratives

    Description of Event or Problem · 1

    OCCLUDED RIGHT AXILLARY-POPLITEAL GRAFT. DR. QUESTIONS IF GRAFT IS DEFECTIVE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 GORE AXILLARY POPLITEAL GRAFT Implant VASCULAR GRAFT DSY GORE AND ASSOCIATES RRT 06100100L 29758-120

    Patients

    Seq Age Sex Outcome Treatment
    1 61 YR Required Intervention