BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MESH - COMPOSIX KUGEL

    MDR report key: 3952030 · Received July 16, 2014

    Report

    Report Number
    1213643-2014-00233
    Event Type
    Injury
    Date Received
    July 16, 2014
    Date of Event
    February 17, 2010
    Report Date
    June 18, 2014
    Manufacturer
    DAVOL INC., SUB. C.R. BARD, INC.
    Product Code
    FTL
    PMA / PMN Number
    K061314
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KY, US
    Reporter Occupation
    ATTORNEY

    Narratives

    Additional Manufacturer Narrative · 1

    CURRENTLY, IT IS UNKNOWN WHETHER THE DEVICE MAY HAVE CAUSED OR CONTRIBUTED TO THE REPORTED EVENT. THE PATIENT'S ATTORNEY DID NOT ALLEGE A SPECIFIC DEVICE FAILURE AND MEDICAL RECORDS HAVE NOT BEEN PROVIDED. WE HAVE CONTACTED THE INITIAL REPORTER TO REQUEST ADDITIONAL INFORMATION AND TO REQUEST RETURN OF THE DEVICE FOR EVALUATION. A MANUFACTURING REVIEW WAS PERFORMED AND FOUND NO EVIDENCE OF A MANUFACTURING RELATED CAUSE FOR THE ALLEGED EVENT. IF ADDITIONAL EVENT AND/OR EVALUATION INFORMATION IS OBTAINED, A FOLLOW UP MDR WILL BE SUBMITTED.

    Description of Event or Problem · 1

    THE FOLLOWING WAS REPORTED TO DAVOL BY THE PATIENT'S ATTORNEY. ON (B)(6) 2009, THE PATIENT WAS IMPLANTED WITH A BARD COMPOSIX KUGEL MESH DURING A VENTRAL HERNIA REPAIR. ON (B)(6) 2010, THE PATIENT UNDERWENT ADDITIONAL SURGERY TO REMOVED THE BARD COMPOSIX KUGEL MESH. THE ATTORNEY'S REPORT ALLEGES PAIN, PERMANENT INJURY, AND EXPLANT OF DEFECTIVE MESH.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    415913 MESH - COMPOSIX KUGEL FTL DAVOL INC., SUB. C.R. BARD, INC. NA HURE0749

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention| S