BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MESH - COMPOSIX KUGEL

    MDR report key: 2820643 · Received October 31, 2012

    Report

    Report Number
    1213643-2012-00746
    Event Type
    Injury
    Date Received
    October 31, 2012
    Date of Event
    August 8, 2006
    Report Date
    March 9, 2009
    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 2008-004. 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 PROVIDED, NO DEFINITIVE CONCLUSIONS CAN BE MADE. THE PT HAS MULTIPLE CO-MORBIDITIES INCLUDING SMOKING, OBESITY, AND ABDOMINAL SURGERIES. IT IS UNCLEAR HOW THE COMPOSIX KUGEL MESH FOLDED OVER. THE INFO PROVIDED INDICATES THAT THE PT 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 CAUSED FOR THE ALLEGED EVENT. THERE IS NO INDICATION OF DEFECTIVE MESH, AND NO PRODUCT HAS BEEN RETURNED. IF ANY ADDITIONAL INFO IS OBTAINED, 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) 2005 - PT UNDERWENT REPAIR OF VENTRAL HERNIA WITH IMPLANT OF COMPOSIX KUGEL MESH. KUGEL MESH. SEVERAL LOOPS OF BOWEL WERE ADHERENT TO THE DEFECT. FROM (B)(6) 2006 - OFFICE VISITS - AT FIRST, INCISION FROM HERNIA REPAIR WAS NOTED TO BE HEALED WITH NO BULGE. PT SEEN ON SUBSEQUENT VISITS AND NOTED TO BE PACKING AND MOVING. SHE DEVELOPED PNEUMONIA AND A PERSISTENT COUGH. ON EXAM, RECURRENCE OF HERNIA WAS PALPABLE AND REDUCIBLE. ON (B)(6) 2006 - PT UNDERWENT REPAIR OF INCISIONAL HERNIA. THE COMPOSIX KUGEL MESH WAS CURLED UNDER THE ANTERIOR ABDOMEN WALL AND CREATED A MASS IN THE PELVIC SIDEWALL. MESH WAS RE-SUTURED. LYSIS OF ADHESIONS WAS PERFORMED. BOWEL WAS FOUND ADHERENT TO HERNIA SAC. ON (B)(6) 2006 - PT UNDERWENT REPAIR OF RECURRENT INCISIONAL HERNIA. THE COMPOSIX KUGEL MESH FOLDED OVER ITSELF STICKING TO THE ABDOMEN WALL. COMPOSIX KUGEL MESH WAS EXPLANTED, AND A NON-BAND MESH WAS IMPLANTED. LYSIS OF ADHESIONS WAS PERFORMED. A SMALL BOWEL RESECTION WAS ALSO COMPLETED, WITH MINIMAL SPILLAGE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MESH - COMPOSIX KUGEL FTL DAVOL INC., SUB. C.R. BARD, INC. NA 43FPD327

    Patients

    Seq Age Sex Outcome Treatment
    1 Disability