BEUDAMED
    FDA Adverse Event Injury Summary report: N

    COMPOSIX MESH E/X

    MDR report key: 1914993 · Received November 30, 2010

    Report

    Report Number
    1213643-2010-00511
    Event Type
    Injury
    Date Received
    November 30, 2010
    Date of Event
    July 27, 2006
    Report Date
    November 1, 2010
    Manufacturer
    DAVOL INC., SUB. C.R. BARD, INC.
    Product Code
    FTL
    PMA / PMN Number
    K002684
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    MEDICAL RECORD REVIEW INDICATES THAT THE PT HAD AND WAS TREATED FOR A RECURRENCE, WHICH IS A KNOWN POSSIBLE ADVERSE EVENT LISTED IN THE IFU. THE MEDICAL RECORD REVIEW ALSO INDICATES A PARTIAL MESH EXPLANT TOOK PLACE AT THE SAME TIME AS THE REPAIR OF THE REOCCURRENCE. IT IS UNCLEAR FROM THE MEDICAL RECORDS PROVIDED WHICH OF THE TWO PREVIOUSLY IMPLANTED MESHES WERE EXPLANTED AT THIS TIME. THE MEDICAL RECORDS PROVIDED DO NOT SPECIFY A SPECIFIC PRODUCT PROBLEM WITH EITHER OF THE IMPLANTED MESHES AND NO PRODUCT WAS RETURNED FOR EVAL, THEREFORE, BASED ON THE CURRENTLY AVAILABLE INFO, THERE IS NO INDICATION THAT A FAILURE IN THE DEVICE CAUSED OR CONTRIBUTED TO THE EVENT. SEE MDR 1213643-2010-00218 FOR INFO RELATED TO THE COMPOSIX E/X MESH IMPLANTED ON (B)(6) 2003.

    Description of Event or Problem · 1

    MEDICAL RECORD REVIEW REVEALED: (B)(6) 2002 - INCISIONAL HERNIA REPAIR WITH COMPOSIX E/X MESH. (B)(6) 2003 - INCISIONAL HERNIA REPAIR WITH COMPOSIX E/X MESH. (B)(6) 2006 - REPAIR OF RECURRENT INCISIONAL HERNIA WITH COMPOSIX E/X MESH. EXCISION OF INTRA-ABDOMINAL FOREIGN BODY/MESH AND REPAIR OF SMALL-BOWEL ENTEROTOMY X 2. INCISION WAS MADE THROUGH PREVIOUS MIDLINE SCAR, DISSECTED DOWN WHERE A PIECE OF MESH WAS ENCOUNTERED. INCISION MADE OVER THIS MESH, EXTENSIVE ADHESIONS INTO THE HERNIA SAC WERE NOTED. SMALL BOWEL WAS NOTED TO BE DENSELY ADHESED TO "FREE FLOATING PORTION OF MARLEX MESH. BOWEL WAS CAREFULLY TAKEN OFF THIS PIECE OF MESH, MESH WAS REMOVED." TWO VERY SMALL ENTEROTOMIES IN THE SMALL BOWEL WERE MADE DURING MESH REMOVAL, THESE WERE REPAIRED AND HERNIA WAS REPAIRED PLACING A LARGE PIECE OF COMPOSIX MESH; RESIDUAL MESH ON THE LEFT SIDE, WHICH WAS WELL SECURED TO FASCIA WAS USED TO FACILITATE CLOSURE ON THE LEFT SIDE WITH THE NEW MESH BEING SUTURED TO THE OLD MESH. PT TO RECOVERY IN STABLE CONDITION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 COMPOSIX MESH E/X FTL DAVOL INC., SUB. C.R. BARD, INC. NA 43DMD103

    Patients

    Seq Age Sex Outcome Treatment
    1 54 YR Required Intervention