BEUDAMED
    FDA Adverse Event Injury Summary report: N

    XENMATRIX

    MDR report key: 8041118 · Received November 6, 2018

    Report

    Report Number
    1213643-2018-03867
    Event Type
    Injury
    Date Received
    November 6, 2018
    Date of Event
    October 16, 2018
    Report Date
    November 6, 2018
    Manufacturer
    DAVOL INC., SUB. C.R. BARD, INC.
    Product Code
    FTM
    UDI-DI
    00801741031380
    PMA / PMN Number
    K081272
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NE, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    NO CONCLUSION CAN BE MADE. BASED ON THE INFORMATION PROVIDED WE ARE UNABLE TO DETERMINE TO WHAT EXTENT, IF ANY, THE XENMATRIX GRAFT MAY HAVE CAUSED OR CONTRIBUTED TO THE PATIENT'S REPORTED STAPH INFECTION. AS REPORTED APPROXIMATELY SIX YEARS POST IMPLANT THE PATIENT WAS DIAGNOSED WITH A STAPH (B)(6) INFECTION, WHICH CAN TYPICALLY BE ACQUIRED DURING HOSPITAL STAYS / VISITS. ADDITIONALLY, MEDICAL IMPLANTS ARE NOT FREQUENTLY THE CAUSE OF THESE TYPES OF RECURRENT INFECTIONS BUT RATHER A VANTAGE POINT THAT THE BACTERIA USE. INFECTION IS LISTED IN THE ADVERSE REACTION SECTION OF THE INSTRUCTIONS-FOR-USE AS A POSSIBLE COMPLICATION. SHOULD ADDITIONAL INFORMATION BE OBTAINED, A SUPPLEMENTAL EMDR WILL BE SUBMITTED. NOT RETURNED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT ON (B)(6) 2011 THE PATIENT WAS IMPLANTED WITH A BARD XENMATRIX GRAFT. THE GRAFT WAS PLACE IN A CLEAN PROCEDURE. AS REPORTED APPROXIMATELY SIX YEARS LATER THE PATIENT DEVELOPED A (B)(6) INFECTION, WHICH HAS RECURRED THREE TIMES. ON (B)(6) 2018 A REVISION PROCEDURE WAS PERFORMED WITH EXCISION OF THE FASCIA, SCAR TISSUE AND EXPLANT OF POTENTIAL BIO MESH REMNANT (XENMATRIX GRAFT). THE CONTACT REPORTS THE CULTURE CAME BACK POSITIVE FOR STAFF INFECTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    881466 XENMATRIX PORCINE SURGICAL MESH FTM DAVOL INC., SUB. C.R. BARD, INC. NA HUVCBL30 00801741031380

    Patients

    Seq Age Sex Outcome Treatment
    1 79 YR Required Intervention