BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MESH- COMPOSIX

    MDR report key: 2170007 · Received July 12, 2011

    Report

    Report Number
    1213643-2011-00329
    Event Type
    Injury
    Date Received
    July 12, 2011
    Report Date
    December 22, 2008
    Manufacturer
    DAVOL INC.
    Product Code
    FTL
    PMA / PMN Number
    K971745
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    RI, 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 THE MEDICAL RECORD REVIEW THE PATIENT UNDERWENT REPAIR OF A RECURRENT INCISIONAL VENTRAL HERNIA WITH COMPOSIX MESH ON (B)(6) 2007. THE MEDICAL RECORDS PROVIDED DO NOT INDICATE A DEVICE RELATED FAILURE AS CAUSING OR CONTRIBUTING TO THE REPORTED EVENT. THE PATIENT IS MORBIDLY OBESE AND HAS DEVELOPED AND BEEN TREATED FOR MULTIPLE HERNIA RECURRENCES PRIOR TO THE IMPLANT OF COMPOSIX MESH. THE MEDICAL RECORDS PROVIDED DO NOT INDICATE THAT THERE WAS A DEVICE FAILURE NOR A RECURRENCE AFTER THE IMPLANT OF COMPOSIX MESH. ADDITIONALLY, ACCORDING TO THE MEDICAL RECORDS THE MESH REMAINS IMPLANTED. THERE IS NO INDICATION OF A DEVICE FAILURE.

    Description of Event or Problem · 1

    BASED ON THE MEDICAL RECORDS PROVIDED BY THE PATIENT'S ATTORNEY: (B)(6) 2004 - PATIENT UNDERWENT REPAIR OF EPIGASTRIC AND VENTRAL HERNIA WITH NON-BARD MESH. LYSIS OF ADHESIONS WERE PERFORMED. ON (B)(6) 2005 - PATIENT UNDERWENT REPAIR OF RECURRENT INCISIONAL EPIGASTRIC HERNIA WITH NON-BARD MESH. ON (B)(6) 2007 - PATIENT UNDERWENT REPAIR OF RECURRENT VENTRAL INCISIONAL HERNIA WITH COMPOSIX MESH.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MESH- COMPOSIX FTL DAVOL INC. NA 43CQD225

    Patients

    Seq Age Sex Outcome Treatment
    1 49 YR Required Intervention