BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PROCOL

    MDR report key: 947452 · Received November 9, 2007

    Report

    Report Number
    2031002-2007-00002
    Event Type
    Malfunction
    Date Received
    November 9, 2007
    Report Date
    November 9, 2007
    Manufacturer
    HANCOCK/JAFFE LABORATORIES, INC.
    Product Code
    MAK
    PMA / PMN Number
    PO20049
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    A RETURN KIT WAS SENT TO THE PHYSICIAN IN THE EVENT A SECTION OF GRAFT CAN BE RETURNED FOR ANALYSIS. RECORDS SHOW THAT THE SURGEON IMPLANTED THE SAME PROCOL MODEL IN TWO PTS DURING 2007. IT HAS NOT YET BEEN DETERMINED WHICH SERIAL NUMBER WAS IMPLANTED IN THIS INDIVIDUAL. ADDITIONAL LOT # SB013063

    Description of Event or Problem · 1

    A 10CM GRAFT SEGMENT WAS IMPLANTED TO BYPASS AN INFECTED SEGMENT OF AN EXISTING FORARM EPTFE HEMODIALYSIS ACCESS GRAFT. APPROX FOUR MONTHS POSTOPERATIVELY, THE PT PRESENTED WITH "ANEURYSMAL CHANGES" AND NECROTIC APPEARING SKIN OVER THE GRAFT. THE PHYSICIAN DESCRIBED NUMBEROUS NEEDLE HOLES INDICATING A LACK OF NEEDLE ROTATION DURING CANNULATION. GRAFT REPLACEMENT IS PLANNED AND PENDING AS OF THE TIME OF THIS INITIAL REPORT. THE DEVICE HAS NOT YET BEEN RETURNED FOR ANALYSIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PROCOL VASCULAR ACCESS GRAFT MAK HANCOCK/JAFFE LABORATORIES, INC. HJL016-10-N SB013062

    Patients

    Seq Age Sex Outcome Treatment
    1 YR