BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MESH COMPOSIX KUGEL

    MDR report key: 2801688 · Received October 12, 2012

    Report

    Report Number
    1213643-2012-00691
    Event Type
    Injury
    Date Received
    October 12, 2012
    Date of Event
    May 23, 2006
    Report Date
    July 17, 2009
    Manufacturer
    DAVOL INC., SUB. C.R. BARD, INC.
    Product Code
    FTL
    PMA / PMN Number
    K003323
    Removal / Correction Number
    Z-0760-06
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    BASED ON THE INFO PROVIDED, IT IS UNK WHETHER THE DEVICE MAY HAVE CAUSED OR CONTRIBUTED TO THE REPORTED EVENT. THE PT HAS CO-MORBIDITIES INCLUDING DIVERTICULOSIS, COLON POLYPS, PROSTATE CANCER AND CHEMOTHERAPY. 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 INFO BECOMES AVAILABLE, A FOLLOW-UP MDR WILL BE SUBMITTED.

    Description of Event or Problem · 1

    THE FOLLOWING IS BASED ON THE MEDICAL RECORDS PROVIDED BY THE PT'S ATTORNEY: (B)(6) 2004 - PT UNDERWENT REPAIR OF INCARCERATED LEFT VENTRAL HERNIA WITH IMPLANT OF A COMPOSIX KUGEL MESH. THE HERNIA SAC WAS OPENED AND INCARCERATED OMENTUM AND COLON WERE DISSECTED. IN TWO AREAS, THE COLON HAD TO BE TREATED LIKE A SLIDING HERNIA. THE ATTENUATED MUSCLES AND FASCIA WERE DEBRIDED. ON (B)(6) 2006 - PT UNDERWENT EXCISION OF A MESHOMA OF THE COMPOSIX KUGEL MESH. THE MESH AND A SMALL RIM OF FASCIA WERE EXCISED ON ALL SIDES. SOME MESH THAT WAS UNDERNEATH THE FASCIA AND NOT INVOLVED WAS LEFT BEHIND.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MESH COMPOSIX KUGEL FTL DAVOL INC., SUB. C.R. BARD, INC. NA 43BOD254

    Patients

    Seq Age Sex Outcome Treatment
    1 71 YR Required Intervention