BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MESH - COMPOSIX KUGEL

    MDR report key: 2161668 · Received July 7, 2011

    Report

    Report Number
    1213643-2011-00321
    Event Type
    Injury
    Date Received
    July 7, 2011
    Report Date
    June 3, 2009
    Manufacturer
    DAVOL INC
    Product Code
    FTL
    PMA / PMN Number
    K003323
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, 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 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. BASED ON THE MEDICAL RECORDS PROVIDED, THE PATIENT WAS TREATED FOR A PARASTOMAL HERNIA WITH A COMPOSIX KUGEL MESH ON (B)(6) 2006. THE OPERATIVE REPORT NOTES THAT A 2.5 CM HOLE WAS CUT IN THE CENTER OF THE MESH BEFORE IT WAS PLACED. THE "WARNINGS" SECTION OF THE IFU STATES: DO NOT CUT OR RESHAPE THE BARD COMPOSIX KUGEL HERNIA PATCH, AS THIS COULD AFFECT ITS EFFECTIVENESS. IF THE POSIFLEX MONOFILAMENT IS CUT OR DAMAGED DURING INSERTION OR FIXATION, ADDITIONAL COMPLICATION MAY INCLUDE BOWEL OR SKIN PERFORATION AND INFECTION. THE MEDICAL RECORDS PROVIDED TO NO INDICATE THAT THE DEVICE FAILED. THERE IS REFERENCE TO A PROCEDURE ON (B)(6) 2010, IN WHICH A PARASTOMAL HERNIA REPAIR IS MADE AND ANOTHER MANUFACTURER'S MESH IS PLACED. HOWEVER, THERE IS NO OPERATIVE REPORT PROVIDED AND NO INDICATION THAT THE COMPOSIX KUGEL WAS EXPLANTED. WHILE THERE IS NO EVIDENCE OF A DEVICE FAILURE IN THE MEDICAL RECORDS PROVIDED, WITHOUT FURTHER INFORMATION REGARDING THE PATIENT'S COURSE OF TREATMENT, NO CONCLUSION CAN BE DRAWN.

    Description of Event or Problem · 1

    BASED ON A REVIEW OF MEDICAL RECORDS PROVIDED BY PATIENT'S ATTORNEY: (B)(6) 2006 - REPAIR OF PARASTOMAL HERNIA WITH COMPOSIX KUGEL MESH, EXTENSIVE ENTEROLYSIS. MESH NOTED TO HAVE HAD A 2.5CM CUT MADE IN ITS CENTER. ON (B)(6) 2008 - PARASTOMAL HERNIA REPAIR WITH NON-BARD MESH ON RIGHT LOWER QUADRANT, ILEOSTOMY STOMA CHANGE FROM RIGHT TO LEFT LOWER QUADRANT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MESH - COMPOSIX KUGEL FTL DAVOL INC NA 43FQD154

    Patients

    Seq Age Sex Outcome Treatment
    1 NI Required Intervention