BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MESH - COMPOSIX KUGEL

    MDR report key: 1905788 · Received November 17, 2010

    Report

    Report Number
    1213643-2010-00489
    Event Type
    Injury
    Date Received
    November 17, 2010
    Date of Event
    October 25, 2010
    Report Date
    October 25, 2010
    Manufacturer
    DAVOL INC., SUB. C.R. BARD, INC.
    Product Code
    FTL
    PMA / PMN Number
    K003323
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    WE HAVE CONTACTED THE INITIAL REPORTER TO REQUEST ADD'L INFO AND TO REQUEST RETURN OF THE DEVICE FOR EVAL. THE INFO PROVIDED INDICATES THAT THE DEVICE WAS DISCARDED AND THEREFORE IS NOT AVAILABLE FOR EVAL. THIS MDR INCLUDES ALL PT, EVENT AND DEVICE INFO DAVOL HAS RECEIVED TO DATE. 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. SEE MDR 1213643-2010-00490 FOR INFO RELATED TO THE XENMATRIX GRAFT.

    Description of Event or Problem · 1

    IN 2003 - PT UNDERWENT COMPOSIX KUGEL MESH IMPLANT. UNK HERNIA REPAIR SITE. IN (B)(6) 2010 - PT EXPERIENCED ABDOMINAL PAIN. ON (B)(6) 2010 - PT UNDERWENT COMPOSIX KUGEL MESH EXPLANT PROCEDURE. AT THE TIME OF THE EXPLANT PROCEDURE, THE PT HAD BOWEL PERFORATIONS AND ENTEROTOMIES, AND AN E-COLI INFECTION. THE SURGEON NOTED A BROKEN RING ON THE MESH. THE BOWEL WAS REPAIRED AND A PIECE OF XENMATRIX WAS IMPLANTED INTO THE SITE. THE ABDOMEN/FASCIA WAS CLOSED AT THE TIME OF THE EXPLANT PROCEDURE. IN 2010 - THE PT WAS DIAGNOSED WITH A SEROMA AT THE SITE OF THE XENMATRIX IMPLANT. A WOULD VAC WAS PLACED. (UNK VAC SETTINGS AND DRESSINGS). ON (B)(6) 2010 - PT UNDERWENT XENMATRIX EXPLANT PROCEDURE. THE MD NOTED THE GRAFT HAD HOLES IN IT AND WAS NOT INCORPORATED. THE AREA OF NON-INCORPORATION EXTENDED THROUGHOUT THE GRAFT, INCLUDING THE SUTURE LINE SITE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MESH - COMPOSIX KUGEL FTL DAVOL INC., SUB. C.R. BARD, INC. NA NI

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention