BEUDAMED
    FDA Adverse Event Injury Summary report: N

    COMPOSIX MESH E/X

    MDR report key: 2170064 · Received July 13, 2011

    Report

    Report Number
    1213643-2011-00333
    Event Type
    Injury
    Date Received
    July 13, 2011
    Report Date
    December 10, 2008
    Manufacturer
    DAVOL 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

    THE DEVICE ASSOCIATED WITH THIS EVENT WAS ORIGINALLY REPORTED TO DAVOL AS A RECALLED COMPOSIX KUGEL MESH; THEREFORE, DAVOL ORIGINALLY REPORTED THIS EVENT TO THE FDA IN ACCORDANCE WITH RAE (B)(4). SUBSEQUENTLY, DAVOL HAS RECEIVED ADDITIONAL EVENT INFORMATION INDICATING THAT THE ASSOCIATED EVENT DEVICE IS NOT A RECALLED COMPOSIX KUGEL MESH; THEREFORE, WE ARE SUBMITTING THIS MDR BASED ON THE ADDITIONAL INFORMATION RECEIVED. BASED ON A REVIEW OF THE PROVIDED MEDICAL RECORDS, THE PATIENT HAD AN INCISIONAL HERNIA SECONDARY TO A PREVIOUS C-SECTION REPAIRED WITH A MARLEX MESH ON (B)(6) 2005. THE PATIENT WAS TREATED FOR A RECURRENCE ON (B)(6) 2007. DURING THIS PROCEDURE, THE PREVIOUSLY IMPLANTED MESH WAS EXPLANTED AND A BARD COMPOSIX KUGEL WAS IMPLANTED. ON (B)(6) 2009, THE PATIENT WAS AGAIN TREATED FOR RECURRENCE. DURING THIS PROCEDURE, THE PREVIOUSLY PLACED COMPOSIX KUGEL WAS EXPLANTED AND A COMPOSIX E/X MESH WAS IMPLANTED. BASED ON THE MEDICAL RECORDS PROVIDED, THIS MESH WAS NOT EXPLANTED, AND THERE IS NO INDICATION THAT A FAILURE OF THE COMPOSIX E/X OCCURRED. REFER TO MDR 1213643-2009-00058 FOR INFORMATION REGARDING THE COMPOSIX KUGEL IMPLANTED ON (B)(6) 2007

    Description of Event or Problem · 1

    BASED ON A REVIEW OF MEDICAL RECORDS PROVIDED BY PATIENT'S ATTORNEY: ON (B)(6) 2005 - UMBILICAL/VENTRAL HERNIA SECONDARY TO PREVIOUS C-SECTION REPAIRED WITH MARLEX MESH. ON (B)(6) 2007 - LYSIS OF ADHESIONS WITH EXTENSIVE MANIPULATION OF SMALL BOWEL LOOPS, REPAIR OF RECURRENT INCISIONAL VENTRAL ABDOMINAL WALL HERNIA WITH COMPOSIX KUGEL MESH, PREVIOUS MESH EXPLANTED. ON (B)(6) 2009 - REPAIR OF RECURRENT VENTRAL HERNIA WITH COMPOSIX E/X MESH. COMPOSIX KUGEL MESH EXPLANTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 COMPOSIX MESH E/X FTL DAVOL INC. NA HURD0855

    Patients

    Seq Age Sex Outcome Treatment
    1 NI Other