BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MESH - COMPOSIX KUGEL

    MDR report key: 1719719 · Received May 20, 2010

    Report

    Report Number
    1213643-2010-00233
    Event Type
    Injury
    Date Received
    May 20, 2010
    Date of Event
    January 18, 2010
    Report Date
    April 21, 2010
    Manufacturer
    DAVOL INC., SUB. C.R. BARD, INC.
    Product Code
    FTL
    PMA / PMN Number
    K003323
    Removal / Correction Number
    Z-0524-06
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    CURRENT, IT IS UNK WHETHER OR NOT THE DEVICE MAY HAVE CAUSED OR CONTRIBUTED TO THE EVENT AS NO PRODUCT HAS BEEN RETURNED. NO CONCLUSION CAN BE DRAWN AT THIS TIME. NO INITIAL REPORTER CONTACT INFO INCLUDED ON THE MAUDE REPORT, THEREFORE NO FOLLOW-UP CAN BE MADE. WE, THEREFORE, CONSIDER THIS REPORT COMPLETE TO THE BEST OF OUR CURRENT KNOWLEDGE.

    Description of Event or Problem · 1

    INFO RECEIVED VERBATIM FROM MAUDE EVENT REPORT RECEIVED FROM THE FDA: HAD A DAVOL KUGEL COMPOSIX MESH PLACED 2005. THIS WAS DONE LAPAROSCOPICALLY. MESH WAS MODEL #0010206, SIZE WAS 22.1 X 27.1 CM. PT DID WELL FOR YEARS UNTIL 2009, WHEN HE PRESENTED WITH AN ABDOMINAL INFECTION/ABSCESS OVER THE MESH. THIS OCCURRED AFTER AN EPISODE OF BRONCHITIS. MESH WAS REMOVED ON 2010. RINGS IN MESH HAD FRACTURED AND PERFORATED THE SMALL BOWEL. MESH REPLACED WITH BIOLOGIC MESH. PT IS DOING WELL WITH A SLOWLY HEALING WOUND.

    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 Life Threatening