BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VASCU-GUARD PERIPHERAL VASCULAR PATCH

    MDR report key: 1307804 · Received February 5, 2009

    Report

    Report Number
    2183620-2009-00002
    Event Type
    Injury
    Date Received
    February 5, 2009
    Date of Event
    December 15, 2008
    Report Date
    February 5, 2009
    Manufacturer
    SYNOVIS SURGICAL INNOVATIONS
    Product Code
    DXZ
    PMA / PMN Number
    K983602
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE VASCU-GUARD PERIPHERAL VASCULAR PATCH IS STILL IMPLANTED IN THE PT; THEREFORE, NO PRODUCT WAS RETURNED FOR EVAL. ACCORDING TO THE DEVICE HISTORY RECORD, THE DEVICES MET SPEC AT THE TIME OF MFR. THE 100% STERILITY CHECK PASSED IN ALL CASES WITH NO PSI INDICATED.

    Description of Event or Problem · 1

    PT UNDERWENT REVISION TO THE LEFT FEMORAL AND EXHIBITED AN INFECTION POST-OPERATIVELY. NO ADDITIONAL DETAILS ARE AVAILABLE AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 VASCU-GUARD PERIPHERAL VASCULAR PATCH VASCULAR PATCH DXZ SYNOVIS SURGICAL INNOVATIONS VG-0108N 5746079-921017

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Other