BEUDAMED
    FDA Adverse Event Injury Summary report: N

    COMPOSIX MESH E/X

    MDR report key: 2151626 · Received June 29, 2011

    Report

    Report Number
    1213643-2011-00316
    Event Type
    Injury
    Date Received
    June 29, 2011
    Report Date
    June 7, 2011
    Manufacturer
    DAVOL INC
    Product Code
    FTL
    PMA / PMN Number
    K002684
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    RI, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    BASED ON THE ATTORNEY'S REPORT, THE PATIENT UNDERWENT A HERNIA REPAIR WITH A COMPOSIX E/X MESH ON (B)(6) 2003. ON (B)(6) 2005, THE PATIENT UNDERWENT ANOTHER HERNIA REPAIR WITH TWO BARD COMPOSIX KUGEL MESHES. THE ATTORNEY ALLEGES THAT THE COMPOSIX E/X WAS EXPLANTED, THOUGH NO SPECIFIC DATE OF EXPLANT WAS PROVIDED. CURRENTLY, IT IS UNKNOWN WHETHER THE DEVICE MAY HAVE CAUSED OR CONTRIBUTED TO THE EVENT. NO MEDICAL RECORDS HAVE BEEN PROVIDED, NO SPECIFIC DEVICE FAILURE OR PATIENT INJURY HAS BEEN ALLEGED AND NO PRODUCT HAS BEEN RETURNED. WITH THE INFORMATION PROVIDED, NO CONCLUSION CAN BE DRAWN. THE COMPOSIX KUGEL MESHES ALLEGEDLY IMPLANTED ON (B)(6) 2005 ARE BEING FIELD WITH THE FDA UNDER (B)(4).

    Description of Event or Problem · 1

    BASED ON ATTORNEY'S REPORT: (B)(6) 2003 - HERNIA REPAIR MADE WITH BARD COMPOSIX E/X MESH. ON (B)(6) 2005 - HERNIA REPAIR MADE WITH TWO BARD COMPOSIX KUGEL HERNIA PATCHES. COMPOSIX E/X MESH EXPLANTED. ATTORNEY ALLEGES PATIENT SUFFERED SERIOUS AND PERMANENT INJURIES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 COMPOSIX MESH E/X FTL DAVOL INC NA 43HMD234

    Patients

    Seq Age Sex Outcome Treatment
    1 NI Required Intervention| S