BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MESH - COMPOSIX KUGEL

    MDR report key: 2871999 · Received December 6, 2012

    Report

    Report Number
    1213643-2012-00839
    Event Type
    Injury
    Date Received
    December 6, 2012
    Date of Event
    May 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 ADD'L EVENT INFO INDICATING THAT THE ASSOCIATED EVENT DEVICE IS NOT A RECALLED COMPOSIX KUGEL MESH; THEREFORE WE ARE SUBMITTING THIS MDR BASED ON THE ADD'L INFO RECEIVED. BASED ON THE INFO PROVIDED, NO DEFINITIVE CONCLUSIONS CAN BE MADE. THE PT HAS MULTIPLE CO-MORBIDITIES INCLUDING HYPERTENSION, CORONARY ARTERY DISEASE, AND BLADDER CANCER. IT IS NOTED THAT SHORTLY AFTER HAVING THE DRAIN REMOVED, THE PT DEVELOPED SOME PURULENT DRAINAGE, AND WAS STARTED ON AN ANTIBIOTIC. IT APPEARS THAT THE PT HAD DEVELOPED A FOREIGN BODY REACTION TO THE SUTURES. THE COMPOSIX KUGEL MESH WAS EXPLANTED, ALONG WITH THE SUTURES. THE DEFECT WAS REPAIRED WITH A NON-BARD MESH. IT WAS UNCLEAR IF THE MESH HAD BECOME INFECTED. A LOG NUMBER WAS NOT PROVIDED, THEREFORE A MFG REVIEW IS NOT POSSIBLE. THERE IS NO INDICATION OF DEFECTIVE MESH, NO CULTURE REPORTS PROVIDED. ADDITIONALLY, NO PRODUCT HAS BEEN RETURNED FOR EVAL. IF ANY ADD'L INFO IS OBTAINED, A F/U MDR WILL BE SUBMITTED.

    Description of Event or Problem · 1

    THE FOLLOWING IS BASED ON INFO PROVIDED BY THE PT'S ATTORNEY: ON (B)(6) 2006, PT HAD DEVELOPED A SMALL BOWEL OBSTRUCTION SECONDARY TO INCARCERATED VENTRAL INCISIONAL HERNIA. HERNIA WAS REPAIRED WITH IMPLANT OF COMPOSIX KUGEL MESH. ON (B)(6) 2007, OFFICE VISIT: PT WAS COMPLAINING OF DRAINAGE IN THE UMBILICUS. THERE WAS SOME GRANULATION TISSUE FELT TO BE 'SPITTING' SUTURE. THE PHYSICIAN WAS ABLE TO PALPATE PART OF THE MESH, AND SCHEDULED SURGERY FOR HERNIA REPAIR AND EXCISION OF MESH. ON (B)(6) 2007, PT UNDERWENT REPAIR OF VENTRAL INCISIONAL HERNIA A NON-BARD MESH IMPLANTED. IT APPEARS THAT THE COMPOSIX KUGEL MESH WAS EXPLANTED.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR Disability