BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VERITAS COLLAGEN MATRIX

    MDR report key: 1884123 · Received October 21, 2010

    Report

    Report Number
    2183620-2010-00053
    Event Type
    Injury
    Date Received
    October 21, 2010
    Date of Event
    July 1, 2010
    Report Date
    September 24, 2010
    Manufacturer
    SYNOVIS SURGICAL INNOVATIONS
    Product Code
    FTM
    PMA / PMN Number
    K062915
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    NO PRODUCT WAS RETURNED FOR EVAL. THE DEVICE HISTORY RECORD WAS REVIEW. ACCORDING TO THE DEVICE HISTORY RECORD, THE DEVICE MET SPECIFICATION AT THE TIME OF MANUFACTURE.

    Description of Event or Problem · 1

    SAME PROBLEM AND RPTR AS THE FOLLOWING MFR REPORT NUMBER (INVOLVED ONE PT, ONE EVENT AND TWO DEVICES): 2183620-2010-00052. THE PT UNDERWENT A LAPAROTOMY PROCEDURE TO REPAIR A FASCIAL DEFECT MEASURING APPROX 20CM X25CM WHICH RESULTED FROM EXPLANT OF AN UNSPECIFIED SYNTHETIC MESH DUE TO INFECTION. TWO PIECES OF 12X25 VERITAS WERE SUTURED TOGETHER WITH PROLENE SUTURE AND IMPLANTED, USING A BRIDGE TECHNIQUE, OVER GRANULATED TISSUE IN THE ABDOMEN. IT WAS NOTED THAT THE PHYSICIAN HAD CHANGED GLOVES PRIOR TO HANDLING THE TWO PIECES OF VERITAS AND THE DEVICES WERE NOT SOAKED PRIOR TO IMPLANT. TWO DRAINS WERE PLACED AND THE SKIN WAS CLOSED DIRECTLY OVER THE IMPLANTED VERITAS AS IT WAS NOT POSSIBLE TO CLOSE THE SUBCUTANEOUS OR FASCIAL TISSUE DIRECTLY UNDERNEATH. THE PROCEDURE WAS COMPLETED WITH THE PT "RECOVERING WELL" AND BEING RELEASED FROM THE HOSPITAL ON THE 10TH POST-OP DAY. IT WAS NOTED THAT THE DRAIN OUTPUT WAS A "NORMAL LIQUID." APPROX 1 WEEK POST-RELEASE, THE PT EXPERIENCED PAIN AND RETURNED TO THE OPERATING ROOM FOR ABDOMINAL EXPLORATION, WHICH REVEALED A "NEAR COMPLETE LOSS OF VERITAS." IT WAS NOTED THAT THERE WAS NO INCORPORATION OF ANY PART OF EITHER VERITAS PATCH AND BOTH PIECES WERE "COMPLETELY DESTROYED". THERE WAS NO ACTIVE INFECTION NOTED, ONLY FLUID BETWEEN THE VERITAS AND SKIN CLOSURE. THE TISSUE WAS CULTURED AND THE ABDOMINAL DEFECT WAS CLOSED WITH ANOTHER SURGICAL MESH. LABORATORY ANALYSIS OF THE TISSUE CULTURE REVEALED (B)(6). NO ANTIBIOTICS WERE PRESCRIBED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 VERITAS COLLAGEN MATRIX SURGICAL MESH FTM SYNOVIS SURGICAL INNOVATIONS RM 1225 5765456-1276006

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR Required Intervention