BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MESH - COMPOSIX KUGEL

    MDR report key: 2120272 · Received May 31, 2011

    Report

    Report Number
    1213643-2011-00244
    Event Type
    Injury
    Date Received
    May 31, 2011
    Report Date
    February 23, 2010
    Manufacturer
    DAVOL INC
    Product Code
    FTL
    PMA / PMN Number
    K003323
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, 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 (B)(4). SUBSEQUENTLY, DAVOL HAS RECEIVED ADDITIONAL EVENT INFO INDICATING THAT THE ASSOCIATED EVENT DEVICE IS NOT A RECALLED COMPOSIX KUGEL MESH; THEREFORE, WE ARE SUBMITTING THIS MDR BASED ON THE ADDITIONAL INFO RECEIVED. BASED ON THE PROVIDED MEDICAL RECORDS, THE PT WAS TREATED FOR A LEFT INGUINAL HERNIA WITH A COMPOSIX KUGEL MESH ON (B)(6) 2005. A SECOND "HUGE INDIRECT INGUINAL HERNIA" WAS ALSO DISCOVERED DURING THIS PROCEDURE. THE SURGEON NOTED THAT THIS SECOND HERNIA WAS SO INCARCERATED WITH THE PERITONEUM THAT SEVERAL RENTS WERE MADE IN THE PERITONEUM. THE SURGEON ALSO NOTED THAT THE SURGERY TOOK TWICE AS LONG AS A NORMAL HERNIA REPAIR DUE TO ITS DIFFICULTY. TWO YEARS AFTER THE IMPLANT, THE PT WAS ADMITTED TO THE EMERGENCY ROOM FOR CHEST PAIN FOR CORONARY CARE AND CARDIOMYOPATHY. ON (B)(6) 2007, THE PT RETURNED TO THE EMERGENCY ROOM FOR BLOODY DIARRHEA, A COLON BIOPSY ULCER, COLITIS AND RARE CRYPT ABSCESS. THERE IS NO MENTION IN THE MEDICAL RECORDS PROVIDED OF A DEVICE FAILURE. A MANUFACTURING REVIEW WAS PERFORMED AND FOUND NO EVIDENCE OF A MANUFACTURING RELATED CAUSE FOR THE ALLEGED EVENT. BASED ON THE MEDICAL RECORDS PROVIDED, IT DOES NOT APPEAR THAT A DEVICE FAILURE HAS OCCURRED. HOWEVER, WITHOUT ADDITIONAL INFO, NO CONCLUSION CAN BE DRAWN.

    Description of Event or Problem · 1

    BASED ON A REVIEW OF THE MEDICAL RECORDS PROVIDED BY PT'S ATTORNEY: (B)(6) 2005 -- LEFT INGUINAL HERNIA REPAIR WITH COMPOSIX KUGEL MESH. DIRECT HERNIA AND INDIRECT HERNIA IDENTIFIED. SURGEON NOTED PROCEDURE WAS MORE DIFFICULT THAN NORMAL. ON (B)(6) 2007 -- PT ADMITTED TO EMERGENCY ROOM FOR CHEST PAIN TO CORONARY CARE, CARDIOMYOPATHY. ON (B)(6) 2007 -- ER ADMISSION FOR BLOODY DIARRHEA, COLON BIOPSY ULCER, COLITIS, RARE CRYPT ABSCESS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MESH - COMPOSIX KUGEL FTL DAVOL INC NA 43COD277

    Patients

    Seq Age Sex Outcome Treatment
    1 NI Required Intervention