BEUDAMED
    FDA Adverse Event Other Summary report: N

    GELWEAVE STRAIGHT

    MDR report key: 1993395 · Received February 8, 2011

    Report

    Report Number
    9612515-2011-00001
    Event Type
    Other
    Date Received
    February 8, 2011
    Date of Event
    January 19, 2011
    Report Date
    February 9, 2011
    Manufacturer
    VASCUTEK LTD
    Product Code
    DSY
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE AVAILABLE FOR EVALUATION. GRAFT IMPLANTED AND SECTION OF UNUSED GRAFT IS BEING RETURNED FOR INVESTIGATION ONLY. METHOD: MANUFACTURING AND QC RECORDS REVIEWED. RESULTS: THERE WERE A TOTAL OF 44 UNITS IN THE BATCH. THE QUALITY CONTROL AND MANUFACTURING RECORDS WERE REVIEWED AND THERE WAS NOTHING TO SUGGEST ANY PROBLEMS. ALL GRAFTS WERE GELATIN SEALED. AFTER SEALING, 100% OF ALL GRAFTS ARE LEAK TESTED. THE LEAK TEST RESULTS WERE WITHIN OUR SPECIFIED QUALITY CONTROL LIMIT FOR THIS PRODUCT. ALL GRAFTS WERE DISTRIBUTED BETWEEN (B)(4) 2010. THE USAGE RATE OF THIS PARTICULAR MODEL OF GRAFT IS SUCH THAT IT MAY BE ASSUMED THE MAJORITY HAVE NOW BEEN IMPLANTED. NO OTHER REPORTS HAVE BEEN REC'D FOR THE OTHER UNITS. CONCLUSIONS: VASCUTEK WILL RESPOND TO THE SURGEON AND PROVIDE DETAILS OF OUR INVESTIGATION IN OUR FINAL REPORT.

    Description of Event or Problem · 1

    THE EVENT OCCURRED AT (B)(6) IN USA. NO DEATH OR SERIOUS INJURY TOOK PLACE. A GELWEAVE GRAFT WAS CUT TO SIZE AND IN THE DISCARDED PORTION A SMALL GLOBULE OF A GELATINOUS SUBSTANCE WAS NOTED. DURING THE OPERATION THE DOCTOR OBSERVED SUTURE HOLE BLEEDING AND WEEPING FROM THE GRAFT. IT TOOK 4 HOURS TO CONTROL THE BLEEDING. THE PROCEDURE WAS SUCCESSFULLY COMPLETED AND THE PT RECOVERED WELL FROM THE OPERATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 GELWEAVE STRAIGHT VASCULAR PROSTHESIS DSY VASCUTEK LTD GELWEAVE 111802/1A 2404

    Patients

    Seq Age Sex Outcome Treatment
    1 Other