BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BIODESIGN HERNIA GRAFT

    MDR report key: 3997726 · Received July 1, 2014

    Report

    Report Number
    1835959-2014-00243
    Event Type
    Malfunction
    Date Received
    July 1, 2014
    Report Date
    July 1, 2014
    Manufacturer
    COOK BIOTECH, INC.
    Product Code
    FTL
    PMA / PMN Number
    K062697
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    INVESTIGATION TO THIS FEEDBACK INCLUDED A REVIEW OF THE FEEDBACK DETAILS, MEETING OF THE INCIDENT INVESTIGATION COMMITTEE, AND A REVIEW OF THE BIODESIGN HERNIA GRAFT IFU FP0036-02K. ALTHOUGH THE SURGEON ALLEGES THE DEVICE ADHERED TO THE BOWEL AND THEN ERODED THROUGH THE BOWEL, THE ROOT CAUSE OF THE ENTEROCUTANEOUS FISTULA IS INCONCLUSIVE AS THERE WAS NO ACTUAL VISUALIZATION OF THE BOWEL (VIA REOPERATION) TO CONFIRM THIS SCENARIO. HOWEVER, THIS ALSO MEANS THAT THE ALLEGED ADHESION AND EROSION WAS NOT RULED OUT AS THE CAUSE OF THE ENTEROCUTANEOUS FISTULA. AS SUCH, IN A CONSERVATIVE APPROACH TO REPORTING ADVERSE EVENTS, AN MDR WILL BE FILED. THE PATIENT IN THIS CASE HAD A COLOSTOMY TAKEDOWN AND AN ABSCESS, BOTH OF WHICH INCREASE THE SUSPECTABILITY TO FORMING AN ENTEROCUTANEOUS FISTULA. ADDITIONALLY, INJURY TO THE BOWEL DURING SURGERY CAN BE ANOTHER POSSIBLE CONTRIBUTING FACTOR TO AN ENTEROCUTANEOUS FISTULA. THE BIODESIGN HERNIA GRAFT IFU FP0036-02K NOTES THAT "POSSIBLE ADVERSE REACTIONS WITH THE USE OF ANY PROSTHESIS MAY INCLUDE, BUT ARE NOT LIMITED TO... ADHESION... BOWEL EROSION... FISTULA FORMATION. COMPLICATIONS, SUCH AS DELAYED WOUND INFECTION, PREMATURE DEGRADATION, HERNIA RECURRENCE, BOWEL EROSION, AND THE NEED FOR RE-OPERATION, SHOULD BE REASONABLE EXPECTED IN PATIENTS WHO ARE CRITICALLY ILL OR WHO HAVE SEVERELY CONTAMINATED ABDOMENS."

    Description of Event or Problem · 1

    DR (B)(6) PLACED THE DEVICE FOR REINFORCEMENT OF A COLOSTOMY TAKEDOWN. THE PATIENT DEVELOPED AN ABSCESS AT AN UNSPECIFIED TIME FRAME AFTER SURGERY. THE DEVICE WAS NOT ALLEGED TO HAVE CAUSED OR CONTRIBUTED TO THE ABSCESS. THE ABSCESS WAS DRAINED AND PIECES OF THE GRAFT WERE PRESENT IN THE DRAINAGE. THE PATIENT THEN DEVELOPED AN ENTEROCUTANEOUS FISTULA A COUPLE OF WEEKS AFTER GRAFT PLACEMENT. DR (B)(6) SPECULATED THAT THE GRAFT ADHERED TO THE BOWEL AND THEN ERODED THROUGH THE BOWEL WHICH LED TO AN ENTEROCUTANEOUS FISTULA. THE FISTULA SPONTANEOUSLY CLOSED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    381998 BIODESIGN HERNIA GRAFT COMPLEX HERNIA GRAFT EXL FTL COOK BIOTECH, INC. UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Hospitalization NONE REPORTED