BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SOLO PATH

    MDR report key: 5612074 · Received April 22, 2016

    Report

    Report Number
    MW5061890
    Event Type
    Injury
    Date Received
    April 22, 2016
    Date of Event
    April 22, 2016
    Report Date
    April 22, 2016
    Manufacturer
    TERUMO
    Product Code
    DYB
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    CO, US
    Reporter Occupation
    2

    Narratives

    Description of Event or Problem · 1

    THERE WAS A LEAK IN AN OCCLUSION BALLOON THAT REQUIRED A RETROPERITONEAL APPROACH TO CLAMP THE AORTA AND PUT A 10MM HEMASHIELD GRAFT FROM RIGHT COMMON ILIAC TO RIGHT SFA.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    256748 SOLO PATH DYB TERUMO SR-2345 WO38382

    Patients

    Seq Age Sex Outcome Treatment
    1 78 YR Required Intervention