BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PROCOL

    MDR report key: 544865 · Received September 16, 2004

    Report

    Report Number
    2031002-2004-00003
    Event Type
    Injury
    Date Received
    September 16, 2004
    Date of Event
    September 3, 2004
    Report Date
    September 16, 2004
    Manufacturer
    HANCOCK/JAFFE LABORATORIES, INC.
    Product Code
    MDQ
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    A GRAFT WAS IMPLANTED IN THE THIGH AREA FOR AV ACCESS (2004). APPROX TWO WEEKS POST IMPLANT, THE PT PRESENTED TO ANOTHER PHYSICIAN WHO REPORTED THE PRESENCE OF AN ACTIVE INFECTION INVOLVING THE GRAFT. AN OPEN WOUND WITH PURULENCE WAS DESCRIBED NEAR THE AREA OF THE FEMORAL ANASTOMOSIS. THE PHYSICIAN STATED THAT HE COULD NOT DETERMINE THE CAUSE OF THE INFECTION BUT ELECTED TO EXPLANT THE GRAFT TO PREVENT THE PROGRESSION OF THE INFECTION THE GRAFT WAS EXPLANTED IN 2.5 WEEKS. THE EXPLANTED GRAFT WAS NOT RETURNED TO THE MFR FOR INVESTIGATION. THE SERIAL NUMBER WAS NOT IDENTIFIED, HOWEVER, ALL SHIPPED DEVICES ARE CERTIFIED AS STERILE FOLLOWING EXPOSURE TO GAMMA RADIATION. THE INSTRUCTIONS FOR USE WERE REVIEWED. INFECTION IS LISTED AS A POTENTIAL ADVERSE EVENT. IT SHOULD BE NOTED THAT THIS INFECTION OCCURRED WITHIN THE FIRST 30 DAYS OF IMPLANT. EARLY POSTOPERATIVE INFECTION IS NOT UNUSUAL FOLLOWING ANY VASCULAR PROCEDURE, PARTICULARLY IN THE GROIN AREA.

    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. HJL016-40-N UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Hospitalization| R