BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GORE-TEX VASCULAR GRAFT

    MDR report key: 680208 · Received February 23, 2006

    Report

    Report Number
    680208
    Event Type
    Injury
    Date Received
    February 23, 2006
    Date of Event
    August 25, 2005
    Report Date
    February 23, 2006
    Manufacturer
    W.L. GORE & ASSOCIATES
    Product Code
    FIQ
    Adverse Event
    Yes
    Report Source
    User Facility report
    Reporter Location
    PA, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    APPROX 4 DAYS FOLLOWING IMPLANT OF A GORE-TEX VASCULAR GRAFT IN THE FOREARM FOR DIALYSIS ACCESS, THE PT PRESENTED WITH AN ISCHEMIC HAND. THE GRAFT WAS REMOVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 GORE-TEX VASCULAR GRAFT EPTFE VASCULAR PROSTHESIS FIQ W.L. GORE & ASSOCIATES WLG211 03758081

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR Required Intervention