BEUDAMED
    FDA Adverse Event Injury Summary report: N

    XENMATRIX

    MDR report key: 2120243 · Received May 31, 2011

    Report

    Report Number
    1213643-2011-00240
    Event Type
    Injury
    Date Received
    May 31, 2011
    Date of Event
    March 18, 2011
    Report Date
    May 9, 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
    PA, US
    Reporter Occupation
    ATTORNEY

    Narratives

    Additional Manufacturer Narrative · 1

    BASED ON A REVIEW OF THE MEDICAL RECORDS PROVIDED, THE PT UNDERWENT A PROCEDURE TO REPAIR A VENTRAL INCISIONAL HERNIA WITH COMPONENT SEPARATION USING A XENMATRIX GRAFT ON (B)(6) 2010. ON (B)(6) 2011, THE PT REPORTED PAIN AND A CT SCAN WAS PERFORMED. THE SCAN SHOWED A LARGE COLLECTION OF FLUID ANTERIOR TO THE MESH. AFTER CULTURES SHOWED SOME RARE GRAM POSITIVE RODS, THE DECISION WAS MADE TO EXPLANT THE GRAFT. WHILE THERE IS NO INDICATION, THROUGH OPERATIVE OR PATHOLOGY REPORTS, THAT THE GRAFT WAS CONSIDERED TO BE THE SOURCE OF THE INFECTION, IT IS LISTED AS A POSSIBLE ADVERSE REACTION IN THE PRODUCT'S INSTRUCTIONS FOR USE. THE IFU STATES THAT IF AN INFECTION DEVELOPS, TREAT IT AGGRESSIVELY. A MANUFACTURING REVIEW, WHICH INCLUDED VERIFICATION OF STERILITY, DID NOT SHOW EVIDENCE OF A MANUFACTURING RELATED CAUSE FOR THE ALLEGED EVENT. CURRENTLY, IT IS UNK WHETHER THE DEVICE MAY HAVE CONTRIBUTED TO THE ALLEGED EVENT. THE MEDICAL RECORDS DO NOT INDICATE A SPECIFIC DEVICE FAILURE, NO PATHOLOGY REPORTS ASSOCIATED WITH THE GRAFT WERE PROVIDED, AND NO SAMPLE WAS RETURNED FOR EVALUATION. WITH THE INFO AVAILABLE, NO CONCLUSION CAN BE DRAWN.

    Description of Event or Problem · 1

    BASED ON A REVIEW OF MEDICAL RECORDS PROVIDED BY PT'S ATTORNEY: (B)(6) 2010 -- VENTRAL HERNIA REPAIR WITH A XENMATRIX GRAFT. EXTENSIVE INTRA-ABDOMINAL ADHESIOLYSIS. ON (B)(6) 2011 -- EXPLORATORY LAPAROTOMY, DRAINAGE OF ABDOMINAL FLUID COLLECTION WITH REMOVAL OF INFECTED BIOLOGIC MESH, COMPLEX PRIMARY REPAIR OF ABDOMINAL WALL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 XENMATRIX FTM DAVOL INC. NA HUUFBL05

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR Required Intervention