BEUDAMED
    FDA Adverse Event Injury Summary report: N

    XENMATRIX AB

    MDR report key: 6166223 · Received December 12, 2016

    Report

    Report Number
    1213643-2016-00567
    Event Type
    Injury
    Date Received
    December 12, 2016
    Date of Event
    October 17, 2016
    Report Date
    December 12, 2016
    Manufacturer
    DAVOL INC., SUB. C.R. BARD, INC.
    Product Code
    PIJ
    PMA / PMN Number
    K151177
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    BASED ON THE INFORMATION PROVIDED AND THE PATIENT'S COMPLEX MEDICAL/SURGICAL HISTORY, NO CONCLUSION CAN BE MADE AT THIS TIME. INFECTION IS A KNOWN INHERENT RISK OF ANY SURGICAL PROCEDURE, THE WARNING SECTION OF THE IFU STATES, "THIS DEVICE IS NOT INDICATED FOR THE TREATMENT OF INFECTION. IF AN INFECTION DEVELOPS, TREAT THE INFECTION AGGRESSIVELY." A REVIEW OF THE MANUFACTURING RECORDS WAS PERFORMED AND FOUND THAT THE LOT WAS MANUFACTURED TO SPECIFICATION. IF ADDITIONAL INFORMATION IS PROVIDED, A SUPPLEMENTAL MDR WILL BE SUBMITTED. 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. DEVICE REMAINS IMPLANTED.

    Description of Event or Problem · 1

    IT WAS REPORTED TO DAVOL THAT A PATIENT WHO IS PART OF A CLINICAL STUDY EXPERIENCED A POST SURGICAL SITE INFECTION. AS REPORTED THE PATIENT UNDERWENT IMPLANT OF THE XENMATRIX AB GRAFT ON (B)(6) 2016. DURING A FOLLOW UP VISIT, THE PATIENT WAS NOTED TO HAVE A PURULENT AND SEROSANGUINOUS COLLECTION. A SURGICAL DRAIN WAS PLACED ON (B)(6) 2016 IN THE LEFT UPPER QUADRANT IN THE INTRAPERITONEAL SPACE. THIS DRAIN WAS SUBSEQUENTLY REMOVED ON (B)(6) 2016. A SECOND DRAIN WAS PLACED ON (B)(6) 2016 IN THE RIGHT UPPER QUADRANT, RETRO-RECTUS SPACE. THIS DRAIN WAS REMOVED ON (B)(6) 2016. PATIENT WAS DIAGNOSED WITH A SURGICAL SITE INFECTION WITH PURULENT DRAINAGE FROM THE DEEP INCISION. CULTURES WERE OBTAINED WITH BACTERIA IDENTIFIED AS ESCHERICHIA COLI, KLEBSIELLA, ENTEROCOCCUS AND CANDIDA. THIS ADVERSE EVENT WAS CONSIDERED SEVERE AND REQUIRED PROLONGED HOSPITALIZATION AND ADDITIONAL MEDICAL/SURGICAL TREATMENT. THE PATIENT IS NOTED TO HAVE RECOVERED WITH THE INFECTION RESOLVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    817870 XENMATRIX AB PORCINE SURGICAL MESH PIJ DAVOL INC., SUB. C.R. BARD, INC. NA HUAS0662

    Patients

    Seq Age Sex Outcome Treatment
    1 41 YR Hospitalization| R