BEUDAMED
    FDA Adverse Event Other Summary report: N

    PROCOL

    MDR report key: 559340 · Received December 13, 2004

    Report

    Report Number
    2031002-2004-00005
    Event Type
    Other
    Date Received
    December 13, 2004
    Date of Event
    October 6, 2004
    Report Date
    December 9, 2004
    Manufacturer
    HANCOCK JAFFE LABORATORIES, INC.
    Product Code
    MDQ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    IN 2004 A 10 CM LENGTH PROCOL GRAFT WAS ATTACHED TO NATIVE TISSUE TO CREATE AN ACCESS FISTULA IN THE RIGHT UPPER ARM. THE FISTULA WAS SUCCESSFULLY ACCESSED. THE PHYSICIAN REPORTED REDNESS AND IRRITATION OVER THE AREA OF THE GRAFT THAT HAD NOT RESOLVED OVER A THREE MONTH PERIOD. ONE MONTH LATER WHEN THE SITUATION HAD NOT IMPROVED THE PHYSICIAN REMOVED THE GRAFT FOR EVAL AND IMPLANTED A SYNTHETIC GRAFT. INITIAL PATHOLOGY RESULTS FROM THE HOSP SUGGEST ACUTE INFLAMMATORY REACTION TO THE GRAFT. A SPECIMEN IS IN THE PROCESS OF BEING RETURNED TO THE MFR. THIS IS AN INITIAL REPORT ONLY - AN INVESTIGATION WILL BE INITIATED WHEN THE PRODUCT AND REPORTS ARE RECIEVED BY THE MFR. AT THIS TIME THE POTENTIAL INJURY TO THE PT, IF ANY, HAS NOT BEEN DETERMINED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PROCOL BOVINE MESENTERIC VEIN BIOPROSTHESIS FOR VASCULAR ACCESS MDQ HANCOCK JAFFE LABORATORIES, INC. HJL016-10-N SB013059

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Hospitalization NONE KNOWN.