BEUDAMED
    FDA Adverse Event Injury Summary report: N

    XENMATRIX

    MDR report key: 2061229 · Received April 11, 2011

    Report

    Report Number
    1213643-2011-00147
    Event Type
    Injury
    Date Received
    April 11, 2011
    Report Date
    March 16, 2011
    Manufacturer
    DAVOL INC.
    Product Code
    FTM
    PMA / PMN Number
    K081272
    Removal / Correction Number
    Z-01381-2011
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    BASED ON THE INFO RECEIVED, PT WAS TREATED FOR INFECTION AFTER XENMATRIX REPAIR OF VENTRAL HERNIA. A MESH FROM A PREVIOUS REPAIR WAS ALSO EXPLANTED. THERE IS NO INDICATION IN THE INFO PROVIDED THAT THE XENMATRIX GRAFT CONTRIBUTED TO THE INFECTION, HOWEVER, INFECTION IS STATED AS A POSSIBLE ADVERSE REACTION IN THE PRODUCT'S INSTRUCTIONS FOR USE. THE IFU STATES THAT IF AN INFECTION DEVELOPS, TO TREAT IT AGGRESSIVELY. THE PT WAS REPORTED TO HAVE BEEN TREATED WITH PERCUTANEOUS DRAIN PLACEMENT, WOUND MANAGEMENT AND IV ANTIBIOTIC THERAPY. THE PT HAS BEEN DISCHARGED FROM THE HOSP AND IS CURRENTLY RECEIVING PO ANTIBIOTIC THERAPY. THERE IS NO REFERENCE TO AN EXPLANT OF THE GRAFT, NOR IS THERE AN ALLEGATION OF A DEVICE FAILURE. WITH THE INFO AVAILABLE, IT DOES NOT APPEAR THAT A FAILURE OF THE XENMATRIX GRAFT HAS OCCURRED. THIS MDR INCLUDES ALL PT, EVENT AND DEVICE INFO DAVOL HAS RECEIVED TO DATE.

    Description of Event or Problem · 1

    PER INFO REPORTED TO DAVOL: ON (B)(6) 2010 - PT UNDERWENT XENMATRIX IMPLANT TO REPAIR RECURRENT VENTRAL HERNIA. PT HAS SINCE BEEN DIAGNOSED WITH AN INFECTION, UNDERGONE PERCUTANEOUS DRAIN PLACEMENT, AND ADMITTED TO THE HOSP FOR WOUND MANAGEMENT AND IV ANTIBIOTIC THERAPY. THE PT HAS BEEN DISCHARGED FROM THE HOSP AND IS CURRENTLY RECEIVING PO ANTIBIOTIC THERAPY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 XENMATRIX FTM DAVOL INC. NA HUUIBL04

    Patients

    Seq Age Sex Outcome Treatment
    1 41 YR Required Intervention