BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GELSOFT

    MDR report key: 8419600 · Received March 14, 2019

    Report

    Report Number
    9612515-2019-00003
    Event Type
    Malfunction
    Date Received
    March 14, 2019
    Date of Event
    February 13, 2019
    Report Date
    March 14, 2019
    Manufacturer
    VASCUTEK LTD.
    Product Code
    MAL
    UDI-DI
    05037881110462
    PMA / PMN Number
    P890045/S1
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THIS REPORT IS BEING SUBMITTED AS AN INITIAL / FINAL REPORT. AS NO DEVICE IS BEING RETURNED FOR FURTHER INVESTIGATION, VASCUTEK LTD. NOW CONSIDERS THIS COMPLAINT CLOSED HOWEVER, THE ISSUE WILL BE TRACKED AND TRENDED AS PART OF THE ON-GOING COMPLAINTS TRENDING AND REPORTING PROCESS AND IF AN ADVERSE TREND DEVELOPS ACTION MAY BE TAKEN AT THAT TIME.

    Description of Event or Problem · 1

    EVENT WAS REPORTED TO VASCUTEK LTD. AS FOLLOWS: "AFTER BLOOD FLOW RELEASE THE GRAFT SHOWED A LEAKAGE AT THE SIGHT OF THE BIFURCATE JUNCTION. THE SURGEON APPLIED A FEW STITCHES TO STOP THE BLEEDING".

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    214360 GELSOFT GELSOFT GELATIN IMPREGNATED KNITTED VASCULAR PROSTHESIS MAL VASCUTEK LTD. GELSOFT BIFURCATE 17601138-1664 05037881110462

    Patients

    Seq Age Sex Outcome Treatment
    1 58 YR Required Intervention