BEUDAMED
    FDA Adverse Event Summary report: N

    VASCU-GUARD

    MDR report key: 2457282 · Received February 15, 2012

    Report

    Report Number
    2457282
    Date Received
    February 15, 2012
    Date of Event
    January 30, 2012
    Report Date
    February 15, 2012
    Manufacturer
    SYNOVIS SURGICAL INNOVATIONS
    Product Code
    DXZ
    Report Source
    User Facility report
    Reporter Location
    WA, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    BOVINE VASCU-GUARD GRAFT USED IN CAROTID ENDARTERECTOMY PROCEDURE. PATIENT WAS READMITTED NINE DAYS LATER WITH E. COLI INFECTION OF GRAFT SITE. INCISION WAS SEALED WITH A LIQUID BONDING AGENT THAT SEALS WOUNDS AT TIME OF SURGERY. NO SIGNS OF INFECTION AT TIME OF DISCHARGE TWO DAYS AFTER SURGERY. FAMILY FEELS GRAFT WAS INFECTED AT TIME OF INSERTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 VASCU-GUARD PATCH, PERIPHERAL VASCULAR, BOVINE DXZ SYNOVIS SURGICAL INNOVATIONS VG-0108N 5790031-1676787

    Patients

    Seq Age Sex Outcome Treatment
    1 69 YR