BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VERITAS COLLAGEN MATRIX

    MDR report key: 2003687 · Received February 23, 2011

    Report

    Report Number
    2183620-2011-00018
    Event Type
    Injury
    Date Received
    February 23, 2011
    Date of Event
    January 24, 2011
    Report Date
    January 24, 2011
    Manufacturer
    SYNOVIS SURGICAL INNOVATIONS
    Product Code
    FTM
    PMA / PMN Number
    K062915
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OR, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    A REVIEW OF THE DEVICE HISTORY RECORD WAS NOT POSSIBLE SINCE THE LOT NUMBER WAS UNAVAILABLE. TISSUE SAMPLES WERE RECEIVED BY SYNOVIS AND SENT FOR EVALUATION. TEST RESULTS ARE PENDING.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT AT AN UNSPECIFIED TIME, THE PATIENT UNDERWENT AN EPIGASTRIC HERNIA REPAIR AT WHICH TIME ANOTHER MANUFACTURER'S SURGICAL MESH WAS IMPLANTED. AT AN UNSPECIFIED TIME FOLLOWING THE PROCEDURE, THE PATIENT SUFFERED A RECURRENCE OF THE EPIGASTRIC HERNIA WITH INCARCERATED (STRANGULATED) BOWEL AND LEAKAGE OF BOWEL CONTENTS. IN (B)(6) 2010, THE PATIENT RETURNED TO THE OPERATING ROOM AT WHICH TIME A 12X25 PIECE OF VERITAS WAS IMPLANTED IN THE CONTAMINATED FIELD. THE PATIENT RECOVERED NICELY WITH NO NOTED COMPLICATIONS. IN (B)(6) 2011, APPROXIMATELY 1 YEAR POST-OP, THE PATIENT PRESENTED WITH A BULGE IN THE EPIGASTRIC AREA AND EXAMINATION CONFIRMED REHERNIATION. THE PATIENT WAS TAKEN BACK TO THE OPERATING ROOM FOR REPAIR OF THE HERNIA RECURRENCE. UPON ENTERING THE ABDOMEN, IT WAS NOTED THAT THE VERITAS WAS NICELY INCORPORATED, HOWEVER, A SMALL FRAGMENT, CONSIDERED TO BE VERITAS, WAS EVIDENT. TISSUE SAMPLES WERE EXCISED FROM A LOCATION ROUGHLY LOCATED AT THE CENTER OF THE ABDOMINAL WALL, ALONG THE LINEA ALBA AND WERE REPORTED TO BE THE "SIDES OF THE DEFECT/IMPLANT (NOT THE CENTER)". THE TISSUE SAMPLES WERE RETURNED TO SYNOVIS FOR EVALUATION. NO TISSUE FRAGMENTS OR SAMPLES WERE SENT FOR HOSPITAL LABORATORY ANALYSIS. THE HERNIA WAS REPAIRED WITH ANOTHER MANUFACTURER'S SYNTHETIC MESH. THE PATIENT'S CURRENT STATUS IS REPORTED AS "DOING WELL".

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention