BEUDAMED
    FDA Adverse Event Injury Summary report: N

    COMPOSIX KUGEL

    MDR report key: 2892212 · Received December 21, 2012

    Report

    Report Number
    1213643-2012-00898
    Event Type
    Injury
    Date Received
    December 21, 2012
    Date of Event
    January 12, 2005
    Report Date
    December 7, 2012
    Manufacturer
    DAVOL INC., SUB. C.R. BARD, INC.
    Product Code
    FTL
    PMA / PMN Number
    K003323
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    RI, US
    Reporter Occupation
    ATTORNEY

    Narratives

    Additional Manufacturer Narrative · 1

    INITIALLY, THREE EVENTS WERE REPORTED BY THE PATIENT'S ATTORNEY (REPORTED TO THE FDA VIA MDR NUMBER: 1212643-2011-00733, 1213643-2012-00381, AND 1213643-2012-00402). HOWEVER, REVIEW OF ADD¿L MEDICAL RECORDS SHOWED THERE TO BE AN ADD¿L IMPLANT. SUBSEQUENTLY, DAVOL, INC. IS SUBMITTING THIS MDR BASED ON THE ADD¿L INFO RECEIVED. THE PATIENT HAS CO-MORBIDITIES INCLUDING HYPERTENSION HYPOTHYROIDISM, HEAVY TOBACCO USE, HISTORY OF HEAVY GROWTH ALPHA STREP, AND HAS HAD MULTIPLE ABDOMINAL SURGERIES. BASED ON THE INFO CURRENTLY AVAILABLE, IT IS NOT KNOWN WHETHER THE DEVICE CAUSED OR CONTRIBUTED TO THE ALLEGED ISSUES EXPERIENCED BY THE PATIENT. THERE IS NO INDICATION IN THE MEDICAL RECORDS THAT THE MESH WAS DEFECTIVE. THE INFO PROVIDED INDICATES THAT THE PATIENT WAS TREATED FOR AN INFECTION. WHILE THERE IS NO INDICATION THAT THE MESH WAS THE SOURCE OF THE REPORTED INFECTION, THE WARNING SECTION OF THE IFU STATES ¿IF AN INFECTION DEVELOPS, TREAT THE INFECTION AGGRESSIVELY. THE PROSTHESIS MAY NOT HAVE TO BE REMOVED. AN UNRESOLVED INFECTION, HOWEVER, MAY REQUIRE REMOVAL OF THE PROSTHESIS.¿ A MFG REVIEW OF DEVICE HISTORY RECORDS WAS PERFORMED AND NO EVIDENCE OF A MFG RELATED CAUSE WAS FOUND FOR THE ALLEGED EVENT. NO SAMPLE HAS BEEN RETURNED THEREFORE NO EVALUATION COULD BE PERFORMED. WITHIN THE CURRENTLY AVAILABLE INFO, NO FIRM CONCLUSIONS CAN BE DRAWN. SHOULD ADD¿L EVENT AND / OR EVALUATION INFO BECOME AVAILABLE, THIS FILE WILL BE REVISITED AND A FOLLOW-UP MDR SUBMITTED IF APPLICABLE.

    Description of Event or Problem · 1

    THE INITIAL ATTORNEY REPORT ALLEGED PERMANENT INJURIES, PAIN AND SUFFERING, AND DEFECTIVE MESH AFTER THE IMPLANT OF A COMPOSIX KUGEL MESH. THE FOLLOWING IS BASED ON THE MEDICAL RECORDS PROVIDED BY THE PATIENT¿S ATTORNEY: (B)(6) 2003: REPAIR OF LARGE VENTRAL HERNIA WITH IMPLANT OF COMPOSIX KUGEL MESH. IT WAS NOTED THAT THE PATIENT HAD A ¿SERIES OF HERNIAS¿ WITHIN THE UMBILICUS. A SEPARATE ¿SMALL PIECE OF GRAFT MATERIAL¿ WAS NECESSARY BECAUSE THE COMPOSIX MESH DID NOT QUITE REACH THE ENTIRE DEFECT. THAT PIECE OF GRAFT WAS NOT IDENTIFIED. ON (B)(6) 2003: EMERGENCY ROOM VISIT FOR TREATMENT OF AN ABSCESS AT THE UMBILICUS. CULTURED POSITIVE FOR ALPHA STREP. TREATED WITH ANTIBIOTICS. ON (B)(6) 2005: PATIENT UNDERWENT AN EXPLORATORY LAPAROTOMY WITH A NEAR TOTAL GASTRECTOMY AND SPLENECTOMY. IT IS BELIEVED THAT THE COMPOSIX KUGEL MESH WAS EXPLANTED AT THAT TIME AS THE PATHOLOGY REPORT INDICATED RECEIPT OF TWO PIECES OF MESH.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 55 YR Required Intervention