BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MESH - COMPOSIX KUGEL

    MDR report key: 2801729 · Received October 12, 2012

    Report

    Report Number
    1213643-2012-00694
    Event Type
    Injury
    Date Received
    October 12, 2012
    Date of Event
    January 22, 2003
    Report Date
    December 22, 2008
    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

    THE DEVICE ASSOCIATED WITH THIS EVENT WAS ORIGINALLY REPORTED TO DAVOL AS A RECALLED COMPOSIX KUGEL MESH; THEREFORE, DAVOL ORIGINALLY REPORTED THIS EVENT TO THE FDA IN ACCORDANCE WITH RAE 2008-004. SUBSEQUENTLY, DAVOL HAS RECEIVED ADDITIONAL EVENT INFORMATION INDICATING THAT THE ASSOCIATED EVENT DEVICE IS NOT A RECALLED COMPOSIX KUGEL MESH; THEREFORE WE ARE SUBMITTING THIS MDR BASED ON THE ADDITIONAL INFORMATION RECEIVED. THE COMPOSIX KUGEL MESH IMPLANTED ON (B)(6) 2003, WAS REPORTED TO THE FDA IN ACCORDANCE WITH RAE-2008004. BASED ON THE INFORMATION PROVIDED, IT IS UNKNOWN WHETHER THE DEVICE MAY HAVE CAUSED OR CONTRIBUTED TO THE REPORTED EVENT. THE PATIENT HAS CO-MORBIDITIES INCLUDING MORBID OBESITY, LUPUS, FIBROMYALGIA, AND MULTIPLE ABDOMINAL SURGERIES. PRIOR TO SURGERY IN (B)(6) 2002, THE PATIENT WAS ADVISED THAT HER PAIN, WHICH SHE HAS HAD SINCE THE HYSTERECTOMY, MAY NOT RESOLVE. THERE ARE MULTIPLE VISITS TO THE PAIN CLINIC BETWEEN 2003 AND 2004. NOTED ON (B)(6) 2004, PAIN CLINIC VISIT, PATIENT HAS NOT COMPLIED WITH APPOINTMENTS, AND IS DISCHARGED FROM PAIN CLINIC IN GOOD CONDITION WITH REFERRAL TO MASSAGE THERAPIST. PATIENT CONTINUES TO COMPLAIN OF PAIN 1-1/2 YEARS AFTER LAST REPORTED MESH IMPLANT, WITH NO EVIDENCE OF HERNIA RECURRENCE. THE INFORMATION PROVIDED INDICATES THAT THE PATIENT DEVELOPED AND WAS TREATED FOR RECURRENCE AND ADHESIONS, WHICH ARE KNOWN ADVERSE EVENTS LISTED IN THE IFU. A MANUFACTURING REVIEW WAS PERFORMED, AND FOUND NO EVIDENCE OF A MANUFACTURING RELATED CAUSE FOR THE ALLEGED EVENT. THERE IS NO INDICATION OF DEFECTIVE MESH. ADDITIONALLY, IT APPEARS THE MESH REMAINS IMPLANTED, AND NO PRODUCT HAS BEEN RETURNED. IF ANY ADDITIONAL INFORMATION BECOMES AVAILABLE, A FOLLOW-UP MDR WILL BE SUBMITTED. SEE MDR 1213643-2012-00696 FOR INFORMATION RELATED TO THE COMPOSIX MESH IMPLANTED ON (B)(6) 2002. SEE MDR 1213643-2012-00695 FOR INFORMATION RELATED TO THE COMPOSIX MESH IMPLANTED ON (B)(6) 2002. SEE MDR 1213643-2012-00697 FOR INFORMATION RELATED TO THE COMPOSIX KUGEL IMPLANTED ON (B)(6) 2004.

    Description of Event or Problem · 1

    BASED ON THE MEDICAL RECORDS PROVIDED BY THE PATIENT'S ATTORNEY: (B)(6) 2002 - PATIENT UNDERWENT REPAIR OF INCISIONAL HERNIA WITH IMPLANT OF TWO COMPOSIX MESHES. LYSIS OF ADHESIONS WAS PERFORMED. (B)(6) 2002 - ER: PAIN, HEMATOCHEZIA; POSSIBLE DIVERTICULITIS. (B)(6) 2003 - PATIENT UNDERWENT REPAIR OF RECURRENT VENTRAL HERNIA WITH IMPLANT OF COMPOSIX KUGEL MESH. LYSIS OF ADHESIONS WAS PERFORMED. HERNIA APPEARS TO BE AN EXTENSION OF THE PRIOR HERNIA HIDDEN BY THE FALCIFORM LIGAMENT AND FAT IN THE ABDOMINAL CAVITY. COMPOSIX MESHES FROM PRIOR SURGERY ARE BOTH VISUALIZED. (B)(6) 2003 - OFFICE VISIT: PATIENT KICKED IN ABDOMEN 5 DAYS POST-OP. (B)(6) 2003 - LYSIS OF ADHESIONS WAS PERFORMED. PREVIOUS IMPLANTED MESHES WERE VISUALIZED. NO EVIDENCE OF RECURRENCE. NO NOTATION OF DEFECT IN MESH. (B)(6) 2003 - ER VISIT: PAIN OF UNKNOWN ETIOLOGY NEAR KIDNEY; HEMATURIA. CT NEGATIVE FOR STONES. (B)(6) 2003 - PATIENT UNDERWENT IMPLANT OF A SECOND COMPOSIX KUGEL MESH FOR REPAIR OF INCISIONAL HERNIA FROM PREVIOUS LAPAROSCOPIC PORT PLACEMENT. CT WAS NEGATIVE, BUT DEFECT IN EPIGASTRIUM WAS PALPABLE. MARKED ADHESIONS TO PREVIOUS MESH REPAIR. LYSIS OF ADHESIONS PERFORMED. NO EVIDENCE OF RECURRENT HERNIA. (B)(6) 2004 - ACUTE DIVERTICULITIS WITH DIVERTICULOSIS. (B)(6) 2004- LYSIS OF ADHESIONS PERFORMED. PREVIOUS MESH IS REVEALED. PATIENT HAS VENTRAL HERNIA BETWEEN UPPER AND MID PORTION MESH. A THIRD COMPOSIX KUGEL MESH WAS IMPLANTED. (B)(6) 2005 - PATIENT UNDERWENT LOW ANTERIOR RESECTION. IT IS UNCLEAR WHICH TWO MESH WAS ENCOUNTERED ARE DIVIDED TO GAIN ACCESS TO THE ABDOMINAL CAVITY. SHE HAS SCARRED RECTOSIGMOID COLON WITH ADHESIONS, BUT NO DIVERTICULAR DISEASE. LYSIS OF ADHESIONS WAS PERFORMED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MESH - COMPOSIX KUGEL FTL DAVOL INC., SUB. C.R. BARD, INC. NA 41GLDP07

    Patients

    Seq Age Sex Outcome Treatment
    1 38 YR Required Intervention