BEUDAMED
    FDA Adverse Event Injury Summary report: N

    COLLAMEND

    MDR report key: 2071771 · Received April 20, 2011

    Report

    Report Number
    1213643-2011-00172
    Event Type
    Injury
    Date Received
    April 20, 2011
    Date of Event
    August 3, 2009
    Report Date
    November 10, 2010
    Manufacturer
    DAVOL INC.
    Product Code
    FTM
    PMA / PMN Number
    K052322
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    ATTORNEY

    Narratives

    Additional Manufacturer Narrative · 1

    THE PATIENT'S ATTORNEY INITIALLY REPORTED A COMPOSIX MESH, WHICH WAS FILED WITH THE FDA UNDER MDR 1213643-2010-00199 WHEN DAVOL WAS ORIGINALLY MADE AWARE OF THE COMPLAINT. HOWEVER, MEDICAL RECORDS WERE LATER RECEIVED THAT IDENTIFIED AN ADDITIONAL MESH. BASED ON A REVIEW OF THE MEDICAL RECORDS, PATIENT WAS TREATED FOR AN INCARCERATED INCISIONAL HERNIA WITH A BARD COMPOSIX MESH ON (B)(6) 2005. DURING THAT PROCEDURE, AN UNIDENTIFIED MESH FROM A PREVIOUS HERNIA REPAIR WAS ENCOUNTERED. THREE YEARS POST IMPLANT, THE PATIENT WAS TREATED FOR A FISTULOUS TRACT, WHICH WAS ADHERENT TO THE ABDOMINAL WALL AND MESH. THE MESH WAS REMOVED, BUT WAS NOT NOTED AS THE SOURCE OF THE FISTULA. DURING THAT PROCEDURE, SEROSAL TEARS WERE NOTED IN ADDITION TO THE FISTULA, AND A SMALL BOWEL RESECTION WAS PERFORMED. A COLLAMEND PATCH WAS USED TO COMPLETE THIS REPAIR. ON (B)(6) 2008, THE PATIENT UNDERWENT A SKIN GRAFT FOR AN ABDOMINAL WOUND AND A COMPLEX ENTERO-ATMOSPHERIC FISTULA WAS TREATED. NEARLY A YEAR LATER, THE PATIENT AGAIN WAS TREATED FOR A FISTULA. IT WAS NOTED THAT A LOOP OF BOWEL WAS CREATING THE FISTULA. THE MESH WAS EXPLANTED, HOWEVER, THERE WAS NO MENTION OF IT CONTRIBUTING TO THE FISTULA. THE PATIENT ALSO UNDERWENT ANOTHER SMALL BOWEL RESECTION AND ANASTAMOSIS. A STRATTICE MATRIX MESH WAS USED IN THIS REPAIR. THE PATIENT UNDERWENT A SIMILAR PROCEDURE ON (B)(6) 2009, WHICH INCLUDED REMOVAL OF THE NON-BARD MESH, FISTULA REPAIR, SMALL BOWEL RESECTION AND SMALL BOWEL ANASTAMOSIS. ANOTHER NON-BARD MESH WAS USED IN THIS REPAIR. BASED ON THE INFORMATION PROVIDED, IT IS UNKNOWN WHETHER THE BARD DEVICE MAY HAVE CONTRIBUTED TO THE ALLEGED EVENT. HOWEVER, THE PATIENT HAS AN EXTENSIVE HISTORY OF ABDOMINAL SURGERIES THAT HAVE BEEN REPAIRED WITH BOTH BARD AND NON-BARD PRODUCTS, WITH SIMILAR RESULTS. WHILE THERE IS NO INDICATION THAT THE BARD PRODUCTS CONTRIBUTED TO THE ALLEGED EVENTS, FISTULA AND RECURRENCE ARE BOTH NOTED AS POSSIBLE ADVERSE REACTIONS IN THE PRODUCT'S IFU. NO SAMPLES HAVE BEEN RETURNED FOR EVALUATION AND NO SPECIFIC DEVICE FAILURES HAVE BEEN ALLEGED. REFER TO MDR 1213643-2010-00199 FOR THE COMPOSIX MESH IMPLANTED ON (B)(6) 2005.

    Description of Event or Problem · 1

    BASED ON A REVIEW OF MEDICAL RECORDS PROVIDED BY PATIENT'S ATTORNEY: ON (B)(6) 2005 - EXPLORATORY LAPAROTOMY, EXTENSIVE LYSIS OF ADHESIONS, REPAIR OF VENTRAL INCARCERATED INCISIONAL HERNIA WITH BARD COMPOSIX MESH. A MESH FROM A PREVIOUSLY COMPLETED HERNIA REPAIR WAS NOTED. ON (B)(6) 2008 - EXPLORATORY LAPAROTOMY, LYSIS OF ADHESIONS, SMALL BOWEL RESECTION, EXPLANT OF COMPOSIX MESH, REPAIR OF INCISIONAL HERNIA WITH BARD COLLAMEND GRAFT. ON (B)(6) 2008 - LLE TANGENTIAL EXCISION, SPLIT THICKNESS SKIN GRAFT TO ABDOMINAL WOUND, 70 SQ CM APPLICATION OF VAC SUCTION, DRESSING, AND OSTOMY APPLIANCE, DX: LARGE ABDOMINAL HERNIA WITH COMPLEX ENTERO-ATMOSPHERIC FISTULA, OPEN ABDOMEN. ON (B)(6) 2009 - EXPLORATORY LAPAROTOMY, LYSIS OF ADHESIONS, REMOVAL OF MESH, REPAIR OF ENTEROCUTANEOUS FISTULA, SMALL BOWEL RESECTION, SMALL BOWEL ANASTAMOSIS, ABDOMINAL RECONSTRUCTION WITH BILATERAL COMPONENT SEPARATION, PLACEMENT OF STRATTICE MATRIX MESH. ON (B)(6) 2009 - EXPLORATORY LAPAROTOMY, LYSIS OF ADHESIONS, REMOVAL OF MESH, REPAIR OF ENTEROCUTANEOUS FISTULA, SMALL BOWEL RESECTION, SMALL BOWEL ANASTAMOSIS, ABDOMINAL WALL RECONSTRUCTION, PLACEMENT OF STRATTICE MATRIX MESH. ON (B)(6) 2009 - RE-EXPLORED AND NEW WOUND VAC PLACED, LARGE AMOUNT OF INFLAMMATION FOUND, CONTROLLED ABDOMINAL VAC PLACED, PATIENT SENT TO ICU, INTUBATED, NG TUBE AND VAC DRESSING PLACED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 COLLAMEND FTM DAVOL INC. NA DARG0429

    Patients

    Seq Age Sex Outcome Treatment
    1 75 YR Required Intervention