BEUDAMED
    FDA Adverse Event Injury Summary report: N

    XENMATRIX

    MDR report key: 2090013 · Received May 3, 2011

    Report

    Report Number
    1213643-2011-00198
    Event Type
    Injury
    Date Received
    May 3, 2011
    Date of Event
    April 12, 2011
    Report Date
    April 12, 2011
    Manufacturer
    DAVOL INC.
    Product Code
    FTM
    PMA / PMN Number
    K081272
    Removal / Correction Number
    Z-01382-2011
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE PATIENT'S PHYSICIAN REPORTED THAT THE MESH HAD DETERIORATED BETWEEN THE TIME IT WAS IMPLANTED ON (B)(6) 2010 AND THE TIME IT WAS EXPLANTED ON (B)(6) 2011. CULTURE REPORTS FOLLOWING THE EXPLANT INDICATED HEAVY GROWTH OF (B)(6), HOWEVER THE MESH WAS NOT IDENTIFIED AS THE SOURCE OF THAT INFECTION. THE SURGEON LATER REPORTED THAT THE PATIENT IS VRE RESISTENT AND HE BELIEVES THE GRAFT DEGRADATION WAS A RESULT OF CONTAMINATION FROM THE PATIENT'S PREVIOUS ILEOSTOMY SITE. WHILE THE GRAFT WAS NOT INDICATED AS THE SOURCE OF THE INFECTION, IT IS AN ADVERSE REACTION LISTED IN THE PRODUCT'S INSTRUCTIONS FOR USE. THE IFU STATES THAT IF AN INFECTION DEVELOPS, TO TREAT IT AGGRESSIVELY. BASED ON THE INFORMATION RECEIVED FROM THE PATIENT'S PHYSICIAN, IT DOES NOT APPEAR THAT A FAILURE OF THE DEVICE HAS OCCURRED.

    Description of Event or Problem · 1

    ON (B)(6) 2011 - PATIENT'S ABDOMINAL WOUND REPAIRED WITH XENMATRIX GRAFT. NO INFECTION NOTED. ABDOMEN WAS OPEN (CONTAMINATED WOUND CLASS). WOUND VAC DRESSING APPLIED, SILVERTON DRESSING PLACED DIRECTLY ON TOP OF GRAFT THEN COVERED WITH VAC SPONGE. ON (B)(6) 2011 - WOUND VAC DRESSING CHANGED AND MD NOTED GRAFT HAD AREAS OF DISCOLORED SPOTS. GRAFT WAS INTACT. ON (B)(6) 2011 - PIECES OF GRAFT MATERIAL NOTED IN WOUND VAC SUCTION CONTAINER. MD REMOVED DRESSING AND SAYS GRAFT HAD DISINTEGRATED IN THE AREA OF WOUND VAC. MESH EXPLANTED, WOUND WASHOUT PERFORMED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 XENMATRIX FTM DAVOL INC. NA HUVABL18

    Patients

    Seq Age Sex Outcome Treatment
    1 NI Required Intervention WOUND VAC THERAPY