BEUDAMED
    FDA Adverse Event Summary report: N

    INTERGARD KNITTED ULTRATHIN SILVER VASCULAR PROSTHESIS

    MDR report key: 470700 · Received July 4, 2003

    Report

    Report Number
    1640201-2003-00030
    Date Received
    July 4, 2003
    Date of Event
    March 24, 2003
    Report Date
    May 28, 2003
    Manufacturer
    INTERVASCULAR
    Product Code
    DSY
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BE
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    PT UNDERWENT A FEMORO-POPLITEAL IN 2003. 10 DAYS LATER, A PERIGRAFT FLUID COLLECTION WAS OBSERVED. 2 DAYS LATER SITE WAS PUNCTURED TO EVACUATE LIQUID. COLLECTED LIQUID WAS THEN CULTURED AND FOUND NEGATIVE. IT WAS REPORTED THAT THE PT IS NOW DOING WELL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INTERGARD KNITTED ULTRATHIN SILVER VASCULAR PROSTHESIS ANTIMICROBIAL COLLAGEN COATED VASCULAR PROSTHESIS DSY INTERVASCULAR IGKUT0006RS20S 02C01

    Patients

    Seq Age Sex Outcome Treatment
    1 71 YR Other