BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PROCOL

    MDR report key: 1038689 · Received May 2, 2008

    Report

    Report Number
    2031002-2008-00002
    Event Type
    Malfunction
    Date Received
    May 2, 2008
    Date of Event
    April 3, 2008
    Report Date
    May 2, 2008
    Manufacturer
    HANCOCK/JAFFE LABORATORIES, INC.
    Product Code
    MDQ
    PMA / PMN Number
    P020049
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THIS IS AN INITIAL REPORT AND DEVICE IDENTITY, POSSIBLE EVALUATION OF SPECIMEN AND ADDITIONAL DETAILS OF THE CASE ARE NOT YET AVAILABLE. GRAFT DILATATION IS LISTED IN THE LABELING AS HAVING BEEN OBSERVED DURING CLINICAL INVESTIGATION FOR THIS DEVICE.

    Description of Event or Problem · 1

    A GRAFT WAS IMPLANTED IN A FEMALE PATIENT'S ARM FOR USE AS A HEMODIALYSIS ACCESS GRAFT. APPROXIMATELY, 6 MONTHS POSTOPERATIVELY THE GRAFT DIAMETER APPEARED ENLARGED AND THE PHYSICIAN ELECTED TO LIGATE THE GRAFT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PROCOL VASCULAR ACCESS GRAFT MDQ HANCOCK/JAFFE LABORATORIES, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1