BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DIASTAT VASCULAR ACCESS GRAFT

    MDR report key: 21145 · Received April 13, 1995

    Report

    Report Number
    MW1005600
    Event Type
    Malfunction
    Date Received
    April 13, 1995
    Date of Event
    March 24, 1995
    Report Date
    April 4, 1995
    Manufacturer
    W.L. GORE & ASSOCIATES, INC.
    Product Code
    FIQ
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    FL, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    REMOVAL OF VASCULAR GRAFT FROM LEFT ARM DUE TO PROBLEMS OF REPEATED RETHROMBOSIS AFTER DECLOTTING PROCEDURES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 DIASTAT VASCULAR ACCESS GRAFT Implant VASCULAR ACCESS GRAFT FIQ W.L. GORE & ASSOCIATES, INC. D47150 112549 BAA-006

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR Other