BEUDAMED
    FDA Adverse Event Injury Summary report: N

    6MM GORETEX GRAFT

    MDR report key: 22741 · Received June 14, 1995

    Report

    Report Number
    22741
    Event Type
    Injury
    Date Received
    June 14, 1995
    Date of Event
    May 30, 1995
    Report Date
    May 30, 1995
    Manufacturer
    W.L. GORE & ASSOC., INC.
    Product Code
    FIQ
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    VA, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    THE PT'S GRAFT BLED 4 DAYS AGO AND STOPPED. SHE WAS DIALYZED ON 5/30/95. PT CAME TO ER WITH FOREARM BLEEDING, WHEN THE PHYSICIAN OPENED THE WOUND, A FISTULA WAS EXPOSED WHICH BLED PROFUSELY. PT WAS BROUGHT TO OR FOR GRAFT REVISION WITH 2 VASCULAR CLAMPS IN PLACE. GRAFT WAS IMPLANTED APPROX 10 YRS AGO.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 6MM GORETEX GRAFT Implant FIQ W.L. GORE & ASSOC., INC. UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 81 YR Required Intervention