BEUDAMED
    FDA Adverse Event Injury Summary report: N

    COMPOSIX MESH E/X

    MDR report key: 2885106 · Received December 12, 2012

    Report

    Report Number
    1213643-2012-00858
    Event Type
    Injury
    Date Received
    December 12, 2012
    Date of Event
    October 11, 2006
    Report Date
    November 29, 2012
    Manufacturer
    DAVOL INC., SUB. C.R. BARD, INC.
    Product Code
    FTL
    PMA / PMN Number
    K002684
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    BASED ON THE INFORMATION PROVIDED, NO DEFINITIVE CONCLUSIONS CAN BE MADE. THE PT HAS CO-MORBIDITIES INCLUDING KIDNEY DISEASE AND RENAL TRANSPLANT-BILATERAL NEPHRECTOMIES. LESS THAN ONE WEEK AFTER IMPLANT THE PT DEVELOPED HIGH, SPIKING FEVERS DESPITE IV ANTIBIOTIC THERAPY. MESH WAS EXPLANTED 7 DAYS AFTER IMPLANT. THE INFORMATION PROVIDED INDICATES THAT THE PT DEVELOPED AND WAS TREATED FOR INFECTION, HEMATOMA AND SEROMA, WHICH ARE KNOWN ADVERSE EVENTS LISTED IN THE IFU. A REVIEW OF THE MANUFACTURING RECORDS WAS PERFORMED, INCLUDING A REVIEW OF STERILITY RECORDS, AND THERE WAS NO EVIDENCE OF A MANUFACTURING RELATED CAUSE FOR THE REPORTED EVENT. ALTHOUGH THERE WAS NO CULTURE REPORT PROVIDED TO CONFIRM THE INFECTION, THE WARNING SECTION OF THE IFU STATES "IF AN INFECTION DEVELOPS, TREAT THE INFECTION AGGRESSIVELY. THE PROSTHESIS MAY NOT HAVE TO BE REMOVED. AN UNRESOLVED INFECTION, HOWEVER, MAY REQUIRE REMOVAL OF THE PROSTHESIS." THERE IS NO INDICATION OF DEFECTIVE MESH, NO PATHOLOGY TO CONFIRM EXPLANT, AND NO CULTURES, TEST RESULTS OR OFFICE NOTES PROVIDED. ADDITIONALLY, NO PRODUCT HAS BEEN RETURNED FOR EVALUATION. IF ANY ADDITIONAL INFORMATION IS OBTAINED, A FOLLOW-UP MDR WILL BE SUBMITTED.

    Description of Event or Problem · 1

    THE FOLLOWING INFORMATION IS BASED ON MEDICAL RECORDS PROVIDED BY THE PT: ON (B)(6) 2006 - PT UNDERWENT REPAIR OF VENTRAL INCISIONAL HERNIA WITH IMPLANT OF COMPOSIX MESH E/X. ON (B)(6) 2006 - PT UNDERWENT AN EXPLORATORY LAPAROTOMY FOR IRRIGATION AND DEBRIDEMENT OF THE WOUND. A MURKY RESOLVING HEMATOMA AND SEROMA FLUID WERE NOTED. THE INFECTED COMPOSIX MESH E/X WAS EXPLANTED. HERNIA DEFECT WAS REPAIRED WITH IMPLANT OF A NON-BARD MESH. THERE WAS NO EVIDENCE OF INTRA-ABDOMINAL CONTAMINATION OR PURULENCE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 COMPOSIX MESH E/X FTL DAVOL INC., SUB. C.R. BARD, INC. NA 43AQD354

    Patients

    Seq Age Sex Outcome Treatment
    1 42 YR Required Intervention