BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VERITAS COLLAGEN MATRIX

    MDR report key: 2223794 · Received August 18, 2011

    Report

    Report Number
    2183620-2011-00063
    Event Type
    Injury
    Date Received
    August 18, 2011
    Date of Event
    June 20, 2011
    Report Date
    July 19, 2011
    Manufacturer
    SYNOVIS SURGICAL INNOVATIONS
    Product Code
    FTM
    PMA / PMN Number
    K062915
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    NO PRODUCT WAS RETURNED FOR EVAL, AS THE PRODUCT IS CURRENTLY IMPLANTED. THE DEVICE HISTORY RECORD WAS REVIEWED. ACCORDING TO THE DEVICE HISTORY RECORD, THE DEVICE MET SPEC AT THE TIME OF MANUFACTURE.

    Description of Event or Problem · 1

    ON (B)(6) 2011, A 12X25CM PATCH OF VERITAS COLLAGEN MATRIX WAS IMPLANTED TO REPAIR A 10 X 25CM VENTRAL HERNIA USING A BRIDGE TECHNIQUE WITHOUT COMPONENT SEPARATION. THE SURGEON DID NOT RESECT THE SAC. INTERRUPTED SUTURE WAS USED TO SECURE THE PATCH AND TWO DRAINS WERE PLACED. THE PT USED AN ABDOMINAL BINDER POST-OP. ONE WEEK LATER, NO SEROMAS WERE PRESENT AND THE REPAIR WAS INTACT. THE DRAINS AND BINDER WERE REMOVED. THE PT SPENT ABOUT 10 HOURS TRAVELING BY CAR TO F/U WITH THE SURGEON. THE NEXT DAY, THE PT EXPERIENCED LOWER ABDOMINAL PAIN WITH MASSIVE ABDOMINAL SWELLING. A CT SCAN SHOWED A LARGE REHERNIATION WHICH WAS IDENTICAL TO THE PRE-REPAIR. NO INFECTION WAS REPORTED. THE SURGEON SUSPECTED THAT THE PT HAD A ROUGH DAY THAT PERHAPS WAS TOO STRESSFUL. THE PT IS SCHEDULED TO HAVE THE REHERNIATION REPAIRED IN (B)(6) 2011.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 VERITAS COLLAGEN MATRIX SURGICAL MESH FTM SYNOVIS SURGICAL INNOVATIONS RM-1225 5763820-1527787

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Other