BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MESH - COMPOSIX KUGEL

    MDR report key: 2221268 · Received August 17, 2011

    Report

    Report Number
    1213643-2011-00385
    Event Type
    Injury
    Date Received
    August 17, 2011
    Date of Event
    March 1, 2010
    Report Date
    July 28, 2011
    Manufacturer
    DAVOL INC
    Product Code
    FTL
    PMA / PMN Number
    K003323
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    WE HAVE CONTACTED THE INITIAL REPORTER TO REQUEST ADDITIONAL INFO AND TO REQUEST RETURN OF THE DEVICE FOR EVAL. THIS MDR INCLUDES ALL PT, EVENT AND DEVICE INFO DAVOL HAS RECEIVED TO DATE. ALTHOUGH MEDICAL RECORDS WERE NOT PROVIDED, THE ATTORNEY REPORT INDICATES THAT THE PT DEVELOPED AND WAS TREATED FOR ADHESIONS AND FISTULA FORMATION. BOTH OF WHICH ARE KNOWN POSSIBLE ADVERSE EVENTS LISTED IN THE IFU. BASED ON THE CURRENT AVAILABLE INFO, IT IS UNK WHETHER THE DEVICE MAY HAVE CAUSED OR CONTRIBUTED TO THE ALLEGED EVENT. ADDITIONALLY, NO PRODUCT WAS RETURNED FOR EVAL. WITH THE CURRENT AVAILABLE INFO, NO CONCLUSION CAN BE DRAWN AT THIS TIME.

    Description of Event or Problem · 1

    THE FOLLOWING WAS REPORTED BY THE ATTORNEY FOR THE PT: (B)(6) 2004 - THE PT UNDERWENT INCISIONAL HERNIA REPAIR WITH A BARD COMPOSIX KUGEL HERNIA PATCH. ON (B)(6) 2009 - THE PT WAS ADMITTED TO HOSPITAL WITH COMPLAINTS OF EPIGASTRIC PAIN, NAUSEA, AND VOMITING. A CT SCAN REVEALED A SMALL BOWEL OBSTRUCTION. THE PT UNDERWENT LYSIS OF ADHESIONS AND A SMALL BOWEL RESECTION WITH END TO END ILEOCECOSTOMY. HE WAS FOUND TO HAVE A ENTEROCUTANEOUS FISTULA DURING THIS HOSPITALIZATION. IT WAS PLANNED TO TREAT THE FISTULA CONSERVATIVELY. THE PT WAS DISCHARGED (B)(6) 2009. ON (B)(6) 2010 - THE PT PRESENTED TO THE HOSPITAL TO UNDERGO A TAKEDOWN OF THE ENTEROCUTANEOUS FISTULA. DURING THE PROCEDURE, IT WAS NOTED THAT THE "AT THE SITE OF ENTEROCUTANEOUS FISTULA, THERE WERE LOOPS OF SMALL BOWEL THAT WERE DENSELY ADHERENT, AND THIS WAS THE SITE OF THE FISTULOUS COMMUNICATION. THE BOWEL WAS COMMUNICATING WITH A CAVITY IN THE ABDOMINAL WALL, IN WHICH THERE WAS MESH. THIS MESH WAS ALL CURLED UP AND BOWEL WAS DENSELY ADHERENT TO "IT". IT WAS ALSO NOTED THAT THE "APPENDIX ALSO WAS STUCK TO THE FISTULA AND HAD BEEN PART OF THE FISTULA TRACT." THE MESH WAS EXCISED, THE FISTULA AND THE APPENDIX WERE REMOVED, AND THE SMALL BOWEL WAS RESECTED WITH SIDE TO SIDE ANASTOMOSIS. THE WOUND WAS CLOSED AND THE PT WAS TAKEN TO ICU. THE ATTORNEY ALLEGES THE PT HAS SUFFERED AND WILL CONTINUE TO SUFFER PHYSICAL PAIN, SUFFERING AND PHYSICAL DISTRESS. THE PT SUFFERED SERIOUS AND PERMANENT INJURIES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MESH - COMPOSIX KUGEL FTL DAVOL INC NA 43EOD234

    Patients

    Seq Age Sex Outcome Treatment
    1 58 YR Hospitalization| R| S