BEUDAMED
    FDA Adverse Event Other Summary report: N

    VASC-GUARD PERIPHERAL VASCULAR PATCH

    MDR report key: 1077104 · Received July 15, 2008

    Report

    Report Number
    2183620-2008-00024
    Event Type
    Other
    Date Received
    July 15, 2008
    Date of Event
    May 8, 2008
    Report Date
    July 15, 2008
    Manufacturer
    SYNOVIS SURGICAL INNOVATIONS
    Product Code
    FTL
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    SURGEON HAS NOT SUBMITTED ADDITIONAL INFORMATION ON THIS CASE. WHEN INFORMATION BECOMES AVAILABLE, A SUPPLEMENT WILL BE FILED. ADD'L LOT # 761272.

    Description of Event or Problem · 1

    PATIENT HAD A POST OPERATIVE INFECTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 VASC-GUARD PERIPHERAL VASCULAR PATCH VASCULAR PATCH FTL SYNOVIS SURGICAL INNOVATIONS VG-0601N 5737819

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Other