BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MESH - COMPOSIX KUGEL

    MDR report key: 1903382 · Received November 11, 2010

    Report

    Report Number
    1213643-2010-00484
    Event Type
    Injury
    Date Received
    November 11, 2010
    Date of Event
    November 24, 2009
    Report Date
    October 22, 2010
    Manufacturer
    DAVOL INC., SUB. C.R. BARD, INC.
    Product Code
    FTL
    PMA / PMN Number
    K061314
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    RI, 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 REVIEWED TO DATE. A DHR REVIEW HAS BEEN CONDUCTED. ALL PAPERWORK APPEARED COMPLETE AND ACCURATE AND THERE WERE NO MATERIAL ISSUES IDENTIFIED FOR THE REPORTED LOT. CURRENTLY, IT IS UNKNOWN WHETHER OR NOT THE DEVICE MAY HAVE CAUSED OR CONTRIBUTED TO THE EVENT AS NO PRODUCT HAS BEEN RETURNED. NO CONCLUSION CAN BE DRAWN AT THIS TIME.

    Description of Event or Problem · 1

    PER THE ATTORNEY'S REPORT: ON (B)(6) 2008: PATIENT HAD AN OVAL COMPOSIX KUGEL MESH IMPLANTED TO REPAIR A HERNIA DEFECT. ON (B)(6) 2009: PATIENT PRESENTED TO HOSPITAL WITH SEVERE ABDOMINAL PAIN. ON (B)(6) 2009: PATIENT UNDERWENT SURGERY TO REMOVE THE IMPLANTED MESH (NOTE: PARTIAL EXPLANT), WHICH HAD BECOME INFECTED. DURING THE SURGERY IT WAS FOUND THAT THE MESH WAS ADHERENT TO THE SMALL BOWEL AND THAT THE MESH HAD CRUMPLED UPON ITSELF. THE MESH WAS DISSECTED FREE AND REMOVED. A SMALL AMOUNT OF THE MESH, HOWEVER, WAS REQUIRED TO BE LEFT INSIDE THE BODY AS REMOVAL WOULD HAVE JEOPARDIZED THE INTEGRITY OF THE BOWEL WALL (PARTIAL EXPLANT). THE ATTORNEY ALLEGES THAT THE PATIENT HAS SUFFERED AND WILL CONTINUE TO SUFFER PHYSICAL PAIN AND MENTAL ANGUISH. ATTORNEY'S REPORT OF ALLEGED INFECTION, ADHESIONS, ABDOMINAL PAIN, EXPLANT (PARTIAL), CRUMPLED, DEFECTIVE MESH.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MESH - COMPOSIX KUGEL FTL DAVOL INC., SUB. C.R. BARD, INC. NA 43EQD436

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention