BEUDAMED
    FDA Adverse Event Injury Summary report: N

    COMPOSIX MESH E/X

    MDR report key: 2161694 · Received July 7, 2011

    Report

    Report Number
    1213643-2011-00319
    Event Type
    Injury
    Date Received
    July 7, 2011
    Date of Event
    November 24, 2010
    Report Date
    June 20, 2011
    Manufacturer
    DAVOL INC
    Product Code
    FTL
    PMA / PMN Number
    K002684
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    WE HAVE CONTACTED THE INITIAL REPORTER TO REQUEST ADDITIONAL INFORMATION AND TO REQUEST RETURN OF THE DEVICE FOR EVALUATION. THIS MDR INCLUDES ALL PATIENT, EVENT AND DEVICE INFORMATION DAVOL HAS RECEIVED TO DATE. MEDICAL RECORDS HAVE NOT BEEN MADE AVAILABLE. ADDITIONALLY, NO PRODUCT WAS RETURNED FOR EVALUATION. BASED ON THE CURRENTLY AVAILABLE INFORMATION, IT IS UNKNOWN WHETHER THE DEVICE MAY HAVE CAUSED OR CONTRIBUTED TO THE EVENT. NO CONCLUSION CAN BE DRAWN AT THIS TIME.

    Description of Event or Problem · 1

    THE FOLLOWING WAS REPORTED BY THE ATTORNEY FOR THE PATIENT: (B)(6) 2005 - A BARD COMPOSIX E/X MESH, ELLIPTICAL WAS USED TO REPAIR PATIENT'S HERNIA DEFECT. IN (B)(6) 2009: THE PATIENT'S BARD COMPOSIX E/X MESH, ELLIPTICAL HAD BECOME TANGLED AND MIGRATED TOWARD PATIENT'S BOWELS. ON (B)(6) 2010: THE PATIENT UNDERWENT SURGERY TO EXPLANT THE COMPOSIX E/X MESH. THE ATTORNEY FOR THE PATIENT ALLEGES THE PATIENT CONTINUED TO EXPERIENCE ABDOMINAL PAIN AND DISCOMFORT AFTER THE COMPOSIX E/X MESH. THE PATIENT HAS SUFFERED AND WILL CONTINUE TO SUFFER PHYSICAL PAIN. THE PATIENT HAS SERIOUS AND PERMANENT INJURIES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 COMPOSIX MESH E/X FTL DAVOL INC NA 43JOD300

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention| S