BEUDAMED
    FDA Adverse Event Injury Summary report: N

    COMPOSIX E/X

    MDR report key: 7506190 · Received May 11, 2018

    Report

    Report Number
    1213643-2018-01415
    Event Type
    Injury
    Date Received
    May 11, 2018
    Date of Event
    April 8, 2013
    Report Date
    May 11, 2018
    Manufacturer
    DAVOL INC., SUB. C.R. BARD, INC.
    Product Code
    FTL
    UDI-DI
    00801741031168
    PMA / PMN Number
    K002684
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    ATTORNEY

    Narratives

    Additional Manufacturer Narrative · 1

    CURRENTLY, IT IS UNKNOWN TO WHAT EXTENT THE BARD/DAVOL COMPOSIX E/X DEVICE MAY HAVE CAUSED OR CONTRIBUTED TO THE EVENTS AS ALLEGED BY THE PATIENT¿S ATTORNEY. THE INFORMATION PROVIDED ALLEGES THE PATIENT UNDERWENT AN ADDITIONAL SURGERY TO EXPLANT A COMPOSIX E/X DURING WHICH IT IS ALLEGED THAT THE SURGEON NOTED ADHESIONS, RECURRENCE, AND CURLING OF THE MESH; HOWEVER, NO SAMPLE HAS BEEN PROVIDED FOR EVALUATION AND NO MEDICAL RECORDS ARE AVAILABLE. RECURRENCE AND ADHESIONS ARE KNOWN INHERENT RISKS OF HERNIA REPAIR SURGERY AND ARE IDENTIFIED IN THE ADVERSE REACTION SECTION OF THE INSTRUCTIONS-FOR-USE AS A POSSIBLE COMPLICATION. BASED ON THE LIMITED INFORMATION PROVIDED AT THIS TIME, NO CONCLUSIONS CAN BE MADE. SHOULD ADDITIONAL INFORMATION BE PROVIDED A SUPPLEMENTAL EMDR WILL BE SUBMITTED. NOTE: THE INFORMATION PROVIDED BY BARD REPRESENTS ALL OF THE KNOWN INFORMATION AT THIS TIME. DESPITE GOOD FAITH EFFORTS TO OBTAIN ADDITIONAL INFORMATION, THE COMPLAINANT / REPORTER WAS UNABLE OR UNWILLING TO PROVIDE ANY FURTHER PATIENT, PRODUCT, OR PROCEDURAL DETAILS TO BARD. NOT RETURNED.

    Description of Event or Problem · 1

    THE FOLLOWING WAS ALLEGED BY THE PATIENT'S ATTORNEY: ON (B)(6) 2006: THE PATIENT UNDERWENT REPAIR OF MULTIPLE VENTRAL HERNIAS. AS REPORTED, A COMPOSIX E/X 10" X 13", REF NO. 0123113, LOT NO. 43CPD488 WAS IMPLANTED IN THE PATIENT DURING THIS REPAIR. ON (B)(6) 2013: THE PATIENT UNDERWENT SURGERY TO EXPLANT A FAILED COMPOSIX E/X. AS REPORTED, DURING THE SURGERY, THE SURGEON NOTED THAT "APPROXIMATELY 80% OF PREVIOUS COMPOSIX MESH WAS ADHERENT OMENTUM, SMALL BOWEL. THERE WERE RECURRENT HERNIA SUPERIORLY, INFERIORLY, AND TO THE RIGHT LATERAL ASPECT OF THE PREVIOUS REPAIR. THE MESH HAD CURLED, AND THERE WAS EXPOSED POLYPROPYLENE MESH, WITH ADDITIONAL ADHESIONS OF SMALL BOWEL AND COLON TO THE AREA." IT IS ALLEGED THAT THE PATIENT CONTINUES TO EXPERIENCE COMPLICATIONS RELATED TO THE EPTFE BARD MESH (COMPOSIX EX) AND WILL LIKELY REQUIRE ADDITIONAL SURGERIES TO REPAIR THE DAMAGE FROM THE ALLEGEDLY "DEFECTIVE" COMPOSIX EX MESH.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    351572 COMPOSIX E/X SURGICAL MESH FTL DAVOL INC., SUB. C.R. BARD, INC. NA 43CPD488 00801741031168

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention| S