BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MESH-COMPOSIX KUGEL

    MDR report key: 2221581 · Received August 18, 2011

    Report

    Report Number
    1213643-2011-00386
    Event Type
    Injury
    Date Received
    August 18, 2011
    Date of Event
    June 27, 2008
    Report Date
    December 14, 2009
    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
    OH, 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 MEDICAL RECORD REVIEW, A MORBIDLY OBESE PATIENT UNDERWENT REPAIR OF A VENTRAL HERNIA WITH A COMPOSIX KUGEL MESH ON (B)(6) 2005. APPROXIMATELY TWO MONTHS POST-OPERATIVE THE PATIENT WAS EVALUATED FOR ABDOMINAL PAIN, AND WAS NOTED TO HAVE A SEROMA THAT RESOLVED WITHOUT INTERVENTION. THE MEDICAL RECORDS NOTE THAT ON (B)(6) 2007, THE PATIENT UNDERWENT A POSTERIOR LUMBAR FUSION AND ON (B)(6) 2008 THE PATIENT UNDERWENT EXCISION OF THE COMPOSIX KUGEL MESH AND REPAIR OF AN INCARCERATED RECURRENT VENTRAL HERNIA WITH A BARD COMPOSIX E/X MESH. IT WAS NOTED IN THE MEDICAL RECORDS THAT THE PREVIOUSLY PLACED MESH WAS FOUND TO BE "ALL CRUMBLED." IT WAS REPORTED THAT SEVERAL FASCIAL DEFECTS WERE IDENTIFIED AND EACH CONTAINED A PIECE OF OMENTUM ADHERED TO IT. THE MEDICAL RECORDS NOTE THAT THE ADHESIONS WERE ALL TAKEN DOWN BEFORE PLACING THE BARD COMPOSIX E/X MESH. THERE IS NO INDICATION IN THE MEDICAL RECORDS OF AN ISSUE WITH THE COMPOSIX E/X. BASED ON THE INFORMATION PROVIDED, IT IS UNKNOWN WHETHER THE DEVICE MAY HAVE CAUSED OR CONTRIBUTED TO THE REPORTED EVENT. THE MEDICAL RECORDS INDICATED THAT THE PATIENT DEVELOPED A SEROMA AND ADHESIONS BOTH OF WHICH ARE KNOWN POSSIBLE ADVERSE REACTIONS LISTED IN THE IFU. ADDITIONALLY, NO SAMPLE WAS RETURNED FOR EVALUATION. NO CONCLUSION CAN BE DRAWN AT THIS TIME.

    Description of Event or Problem · 1

    BASED ON MEDICAL RECORDS PROVIDED BY THE PATIENT'S ATTORNEY: (B)(6) 2005-PATIENT UNDERWENT REPAIR OF VENTRAL HERNIA WITH A COMPOSIX KUGEL MESH. ON (B)(6) 2005-POST-SURGICAL OFFICE VISIT, PATIENT PRESENTED WITH ABDOMINAL PAIN. ON (B)(6) 2008-PATIENT UNDERWENT EXCISION OF COMPOSIX KUGEL MESH AND IMPLANT OF BARD COMPOSIX E/X MESH.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MESH-COMPOSIX KUGEL FTL DAVOL INC., SUB. C.R. BARD, INC. NA 43END311

    Patients

    Seq Age Sex Outcome Treatment
    1 54 YR Required Intervention