BEUDAMED
    FDA Adverse Event Injury Summary report: N

    XENMATRIX

    MDR report key: 1883842 · Received October 22, 2010

    Report

    Report Number
    1213643-2010-00456
    Event Type
    Injury
    Date Received
    October 22, 2010
    Date of Event
    September 26, 2010
    Report Date
    September 27, 2010
    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
    RI, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    A DHR REVIEW HAS BEEN CONDUCTED. NO MFG DISCREPANCIES WERE FOUND IN THE DHR. ALL MFG OCCURRED TO SPECIFICATION. CERTIFICATE OF STERILITY WAS REVIEWED; THE LOT WAS STERILIZED PER CURRENT VALIDATED STANDARDS. CURRENTLY, IT IS UNK WHETHER OR NOT THE DEVICE MAY HAVE CAUSED OR CONTRIBUTED TO THE EVENT AS NO PRODUCT HAS BEEN RETURNED. NO CONCLUSION CAN BE DRAWN AT THIS TIME. AVAILABLE INFO INDICATES NO DEVICE WILL BE RETURNED. THIS MDR INCLUDES ALL; PT, EVENT AND DEVICE'S INFO DAVOL HAS RECEIVED TO DATE.

    Description of Event or Problem · 1

    ON (B)(6) 2010 - THE PT UNDERWENT PORCINE MESH IMPLANT DURING AN OPEN, VENTRAL HERNIA REPAIR. THE PROCEDURE WAS CONSIDERED TO BE A CLEAN CASE. THE MESH WAS PLACED INTRAPERITONEAL. THE EDGES OF THE DEFECT WERE BROUGHT TOGETHER; THE MESH WAS LYING RELATIVELY FLAT WITH SLIGHT RIPPLING. SUTURES WERE USED FOR FIXATION (UNK TYPE) EVERY 4 TO 5 CM. NO MECHANICAL FIXATION WAS USED. SCISSORS WERE USED TO TAILOR THE MESH INTO A "FOOTBALL" SHAPE. THE PROCEDURE LASTED 2 TO 3 HRS. THE WOUND WAS CLOSED AND NO WOUND VAC WAS USED. ON (B)(6) 2010 - PT PRESENTED POST-OP WITH A HEMATOMA. THE PT WAS DIAGNOSED WITH A PSEUDOMONAS INFECTION AND THE MESH WAS SUBSEQUENTLY EXPLANTED. PT'S WOUND WAS DEBRIDED AND A WOUND VAC WAS PLACED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 XENMATRIX FTM DAVOL INC., SUB. C.R. BARD, INC. NA HUUBBL02

    Patients

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