BEUDAMED
    FDA Adverse Event Injury Summary report: N

    XENMATRIX

    MDR report key: 2011676 · Received March 4, 2011

    Report

    Report Number
    1213643-2011-00063
    Event Type
    Injury
    Date Received
    March 4, 2011
    Report Date
    February 10, 2011
    Manufacturer
    DAVOL INC., SUB. C.R. BARD, INC.
    Product Code
    FTM
    PMA / PMN Number
    K081272
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    DE, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    IT WAS REPORTED THAT THE PT DEVELOPED AN INFECTION ONE WEEK POST-IMPLANT. THE WARNING SECTION OF THE IFU STATES "IF AN INFECTION DEVELOPS, TREAT THE INFECTION AGGRESSIVELY. IT IS UNK WHETHER OR NOT THE DEVICE MAY HAVE CAUSED OR CONTRIBUTED TO THE EVENT BASED ON THE INFO CURRENTLY AVAILABLE. FURTHERMORE, NO PRODUCT HAS BEEN RETURNED. NO CONCLUSION CAN BE DRAWN AT THIS TIME. AVAILABLE INFO INDICATES NO DEVICE WILL BE RETURNED AND/OR ADDITIONAL INFO WILL BE PROVIDED. WE THEREFORE, CONSIDER THIS REPORT COMPLETE TO THE BEST OF OUR CURRENT KNOWLEDGE.

    Description of Event or Problem · 1

    SURGEON REPORTED: PT UNDERWENT XENMATRIX IMPLANT DURING A LARGE VENTRAL HERNIA COMPONENT SEPARATION PROCEDURE. ONE WEEK POSTOP, THE PT WAS DIAGNOSED WITH AN INFECTION AND WOUND DEHISCENCE. THE PT'S WOUND WAS DEBRIDED AND A WOUND VAC WAS PLACED. ON (B)(6) 2011, THE SURGEON REPORTED THE INFECTION IS RESOLVING. THE SURGEON REPORTED THE PT HAS A RASH ON HIS ABDOMEN AND BACK. THE PT IS BEING TREATED WITH STEROIDS FOR THE RASH.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 XENMATRIX FTM DAVOL INC., SUB. C.R. BARD, INC. NA NI

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention STEROID THERAPY| WOUND VAC THERAPY