BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MESH-COMPOSIX

    MDR report key: 2170020 · Received July 12, 2011

    Report

    Report Number
    1213643-2011-00330
    Event Type
    Injury
    Date Received
    July 12, 2011
    Report Date
    February 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 ADD'L EVENT INFO INDICATING THAT THE ASSOCIATED EVENT DEVICE IS NOT A RECALLED COMPOSIX KUGEL MESH; THEREFORE, WE ARE SUBMITTING THIS MDR BASED ON THE ADD'L INFO RECEIVED. BASED ON THE MEDICAL RECORD REVIEW THE PT UNDERWENT REPAIR OF A RECURRENT VENTRAL HERNIA WITH COMPOSIX MESH ON (B)(6) 2005. THE MEDICAL RECORDS PROVIDED DO NOT INDICATE A DEVICE RELATED FAILURE AS CAUSING OR CONTRIBUTING TO THE REPORTED EVENT. THE MEDICAL RECORDS NOTE THE PT UNDERWENT VENTRAL HERNIA REPAIR WITH TWO PIECES OF NON-BARD MESH IN 2000. THE PT WAS TREATED FOR A RECURRENCE WITH COMPOSIX MESH. ADDITIONALLY, 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 PT'S ATTORNEY: ON (B)(6) 2005, PT UNDERWENT REPAIR OF RECURRENT VENTRAL HERNIA WITH COMPOSIX MESH.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MESH-COMPOSIX FTL DAVOL INC NA 43DND394

    Patients

    Seq Age Sex Outcome Treatment
    1 Other