BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MESH - COMPOSIX KUGEL

    MDR report key: 2562777 · Received May 2, 2012

    Report

    Report Number
    1213643-2012-00333
    Event Type
    Injury
    Date Received
    May 2, 2012
    Date of Event
    August 29, 2007
    Report Date
    October 5, 2011
    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
    OTHER

    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 INFO AVAILABLE, NO DEFINITIVE CONCLUSIONS CAN BE DRAWN. THE MEDICAL RECORDS INDICATE THAT THE PT WAS TREATED FOR ADHESIONS, WHICH IS A KNOWN POSSIBLE ADVERSE REACTION LISTED IN THE IFU. A MFG REVIEW WAS PERFORMED AND FOUND NO EVIDENCE OF A MFG RELATED CAUSE FOR THE ALLEGED EVENT. ADDITIONALLY, NO SAMPLE WAS RETURNED FOR EVAL. THE SURGEON NOTED THE PT'S OBSTRUCTION WAS NOT CAUSED BY THE SMALL BOWEL ADHESIONS TO THE MESH. AT THIS TIME, NO CONNECTION CAN BE MADE BETWEEN THE REPORTED EVENT AND THE DAVOL PRODUCT IN QUESTION. IF ADDITIONAL EVENT AND/OR EVAL INFO IS OBTAINED, A F/U MDR WILL BE SUBMITTED. THE MEDICAL RECORDS REFER TO AN ADDITIONAL COMPOSIX KUGEL MESH IMPLANT ON (B)(6) 2006, HOWEVER, THERE WAS NO INDICATION THAT THERE WERE ANY ISSUES RELATED TO THIS DEVICE.

    Description of Event or Problem · 1

    THE INITIAL ATTORNEY REPORT ALLEGED PAIN AND PERMANENT INJURIES DUE TO A DEFECTIVE MESH. THE FOLLOWING IS BASED ON THE MEDICAL RECORDS PROVIDED BY THE PT'S ATTORNEY: (B)(6) 2006 - REPAIR OF TWO INCISIONAL HERNIAS. ONE IN THE MIDLINE AND ONE IN THE LLQ. THE MIDLINE HERNIA WAS REPAIRED FIRST WITH COMPOSIX KUGEL MESH, THROUGH A SEPARATE INCISION, THE LLQ HERNIA WAS REPAIRED WITH A SMALLER SIZE COMPOSIX KUGEL MESH. ON (B)(6) 2007 - EXCISION OF THE COMPOSIX KUGEL MESH THAT HAD PREVIOUSLY BEEN PLACED TO REPAIR THE MIDLINE HERNIA. REPORTEDLY, THE MESH WAS "CRUMPLED AND PUCKERED SUCH THAT THERE WERE DENSE SMALL BOWEL ADHESIONS TO ITS UNDERSURFACE. THESE WERE NOT RESPONSIBLE FOR THE PT'S OBSTRUCTION." A SEPARATE INTRALOOP ADHESIVE BAND HAD CREATED A CLOSED LOOP OBSTRUCTION. THE MESH PLACE IN LLQ WAS IDENTIFIED AND NOTED TO BE FREE OF ADHESIONS, THIS MESH WAS LEFT INTACT. PRIMARY SUTURE REPAIR OF THE HERNIA WAS PERFORMED AND A NON-BARD ADHESION BARRIER WAS PLACED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MESH - COMPOSIX KUGEL FTL DAVOL INC., SUB. C.R. BARD, INC. NA 43FQD193

    Patients

    Seq Age Sex Outcome Treatment
    1 37 YR Disability