BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MESH COMPOSIX KUGEL

    MDR report key: 2232410 · Received August 26, 2011

    Report

    Report Number
    1213643-2011-00402
    Event Type
    Injury
    Date Received
    August 26, 2011
    Report Date
    November 16, 2009
    Manufacturer
    DAVOL INC., SUB. C.R. BARD, INC.
    Product Code
    FTL
    PMA / PMN Number
    K061314
    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 MEDICAL RECORD REVIEW THE PATIENT WAS ONE YEAR POST-OP FROM VENTRAL HERNIA REPAIR WITH A COMPOSIX E/X WHEN A RECURRENT VENTRAL HERNIA DEVELOPED. ON (B)(6) 2007, IT IS REPORTED THAT THE PATIENT UNDERWENT SMALL BOWEL RESECTION, EXCISION OF THE PREVIOUSLY PLACED COMPOSIX E/X, AND RECURRENT VENTRAL HERNIA REPAIR WITH COMPOSIX KUGEL MESH. THE MEDICAL RECORDS PROVIDED DO NOT INDICATE THAT THERE WAS A DEVICE FAILURE RELATED TO THE COMPOSIX KUGEL MESH. ADDITIONALLY, ACCORDING TO THE INFORMATION PROVIDED, THE MESH REMAINS IMPLANTED. NO CONCLUSION CAN BE DRAWN AT THIS TIME. SEE MDR 1213643-2009-00499 FOR INFORMATION REGARDING THE COMPOSIX E/X MESH.

    Description of Event or Problem · 1

    ATTORNEY REPORTED: THE PATIENT SUSTAINED INJURY AND DAMAGES ASSOCIATED WITH USE OF THE DEFECTIVE PRODUCT, BARD COMPOSIX E/X MESH AND BARD COMPOSIX KUGEL MESH. THE PATIENT SUFFERED DAMAGES. SPECIFICALLY, AS A RESULT OF HAVING THE PATCHES IMPLANTED IN THE PATIENT, THE PATIENT SUFFERED DISABLING PAIN AND REQUIRED SURGICAL INTERVENTION. BASED ON MEDICAL RECORDS PROVIDED BY THE PATIENT'S ATTORNEY: (B)(6) 2006-PATIENT UNDERWENT VENTRAL INCISIONAL HERNIA REPAIR WITH A COMPOSIX E/X. ON (B)(6) 2006-OFFICE VISIT NOTE, INCISION TOTALLY HEALED. ON (B)(6) 2007-PATIENT UNDERWENT SMALL BOWEL RESECTION EXCISION OF COMPOSIX E/X, AND RECURRENT VENTRAL HERNIA REPAIR WITH COMPOSIX KUGEL 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 43JQD564

    Patients

    Seq Age Sex Outcome Treatment
    1 69 YR Required Intervention