BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MESH - COMPOSIX

    MDR report key: 2071018 · Received April 19, 2011

    Report

    Report Number
    1213643-2011-00163
    Event Type
    Injury
    Date Received
    April 19, 2011
    Date of Event
    September 7, 2005
    Report Date
    March 29, 2011
    Manufacturer
    DAVOL INC.
    Product Code
    FTL
    PMA / PMN Number
    K971745
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    PATIENT'S ATTORNEY INITIALLY REPORTED A SINGLE COMPOSIX MESH, WHICH WAS FILED WITH THE FDA UNDER MDR 1213643-2010-00501 WHEN DAVOL WAS ORIGINALLY MADE AWARE OF THE COMPLAINT. HOWEVER, MEDICAL RECORDS WERE LATER RECEIVED THAT IDENTIFIED ADDITIONAL MESHES. BASED ON MEDICAL RECORDS, PATIENT WAS TREATED FOR REPAIR OF A RECURRENT PERISTOMAL HERNIA WITH A BARD COMPOSIX MESH ON (B)(6) 2005. PATIENT HAD PREVIOUSLY BEEN TREATED FOR A VENTRAL ABDOMINAL WALL HERNIA USING A BARD MESH ON (B)(6) 2003. ON (B)(6) 2005, PATIENT WAS TREATED FOR A HERNIA RECURRENCE IN THE ABDOMINAL WALL AREA. THE REPORT NOTES THIS REPAIR WAS NOT ASSOCIATED WITH THE PERISTOMAL MESH REPAIR. ON (B)(6) 2005, THE PATIENT UNDERWENT A PARTIAL EXPLANT OF WHAT WAS SAID TO BE INFECTED MESH. THERE WAS NO PATHOLOGY REPORT PROVIDED TO CONFIRM INFECTION. WHICH OR HOW MANY OF THE PREVIOUS MESH PRODUCTS WERE AFFECTED IS NOT SPECIFIED. ON (B)(6) 2006, PATIENT HAD MESH REMOVED. NO SPECIFIC MESH WAS IDENTIFIED, ONLY THAT UNINCORPORATED MESH WAS EXCISED. THE REPORT MENTIONS A CULTURE OF THE WOUND. HOWEVER, NO RESULTS ARE PROVIDED. PATIENT WAS TREATED ON (B)(6) 2006 FOR MULTIPLE RECURRENT HERNIAS USING A BARD COMPOSIX MESH AND FIXATED WITH A PROTACK. A (B)(6) 2006, CT SCAN REPORT NOTED THE PAIN IN THE PATIENT'S SIDES WAS LIKELY DUE TO THE FIXATION STITCHES, AND THAT THERE WERE NO SIGNS OF RECURRENT HERNIA OR INFECTION. ON (B)(6) 2009, PATIENT WAS TREATED FOR ABSCESS, REMOVAL OF INFECTED MESH AND A SMALL BOWEL RESECTION. AMONG THE MESH WAS FOUND "SEVERAL COILED HERNIA TACKS WHICH WERE QUITE SHARP AND WERE FELT TO POSE A SIGNIFICANT RISK TO THE UNDERLYING BOWEL. THE OPERATIVE REPORT NOTES THE PATIENT HAD A HIGH LIKELIHOOD OF HERNIA RECURRENCE. THE PATIENT WAS TREATED FOR RECURRENCE AND ABSCESS, BOTH STATED AS POSSIBLE ADVERSE REACTIONS IN THE PRODUCT'S IFU. BASED ON THE INFORMATION AVAILABLE, IT IS UNKNOWN WHETHER THE BARD DEVICES CONTRIBUTED TO THE ALLEGED EVENTS. NO SAMPLES HAVE BEEN RETURNED AND NO SPECIFIC DEVICE FAILURES HAVE BEEN ALLEGED. REFER TO MDR 1213643-2010-00501 FOR THE MESH IMPLANTED ON (B)(6) 2003, 1213643-2011-00165 FOR THE MESH IMPLANTED ON (B)(6) 2005 AND 1213643-2011-00164 FOR THE MESH IMPLANTED ON (B)(6) 2006.

    Description of Event or Problem · 1

    BASED ON A REVIEW OF MEDICAL RECORDS PROVIDED BY PATIENT'S ATTORNEY: (B)(6) 2003 - EXPLORATORY LAPAROTOMY WITH REPAIR OF INCARCERATED VENTRAL HERNIAS USING BARD COMPOSIX MESH, EXCISION OF UMBILICUS. ON (B)(6) 2005 - REPAIR OF RECURRENT PERISTOMAL HERNIA WITH BARD COMPOSIX MESH, EXCISION OF SEROMA CAVITY. ON (B)(6) 2005 - REPAIR OF INCARCERATED RECURRENT VENTRAL HERNIA WITH BARD COMPOSIX MESH. ON (B)(6) 2005 - PARTIAL EXPLANT OF INFECTED MESH FROM ABDOMINAL WALL. ON (B)(6) 2006 - EXPLANT OF MESH. ABDOMINAL DEFECT CLOSED WITH SUTURES. ON (B)(6) 2006 - REPAIR OF MULTIPLE VENTRAL INCISIONAL HERNIAS WITH BARD COMPOSIX MESH. PROTACK USED FOR FIXATION. ON (B)(6) 2009 - EVACUATION OF ABSCESS WITH DEBRIDEMENT OF ABDOMINAL WALL, LYSIS OF ADHESIONS, PARTIAL EXPLANT OF INFECTED MESH, SMALL BOWEL RESECTION AND PLACEMENT OF WOUND VAC.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MESH - COMPOSIX FTL DAVOL INC. NA NI

    Patients

    Seq Age Sex Outcome Treatment
    1 38 YR Required Intervention| S