BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MESH - COMPOSIX KUGEL

    MDR report key: 1202793 · Received October 15, 2008

    Report

    Report Number
    1213643-2008-00458
    Event Type
    Injury
    Date Received
    October 15, 2008
    Date of Event
    September 16, 2008
    Report Date
    September 16, 2008
    Manufacturer
    DAVOL INC., SUB. C.R. BARD, INC.
    Product Code
    FTL
    PMA / PMN Number
    K003323
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MD, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    EVALUATION OF RETURNED SAMPLE CONFIRMED A BROKEN MESH RING AT THE WELD. THE SUBJECT PRODUCT WAS MANUFACTURED PRIOR TO THE DESIGN CHANGE AND IS PART OF A PREVIOUSLY INITIATED RECALL.

    Description of Event or Problem · 1

    DOCTOR REPORTED: 2004 - PATIENT IMPLANTED WITH A COMPOSIX KUGEL FOR REPAIR OF AN INCISIONAL HERNIA. IN 2004 - SHORTLY AFTER THE IMPLANT SURGERY, PATIENT RETURNED TO SURGEON WITH COMPLAINTS OF PAIN IN HIS LEFT ABDOMEN. CT SCAN WHICH SHOWED A POSSIBLE HEMATOMA IN THE LEFT SIDE AREA OF THE MESH. THIS GOT BETTER. IN 2005 - PATIENT PRESENTED FOR SHOOTING PAIN IN THE LEFT ABDOMEN WHICH SURGEON SUSPECTED WAS NERVE ENTRAPMENT PAIN. IN 2007 - PATIENT CAME TO SEE SURGEON FOR ABDOMINAL PAIN WITHIN THE LAST 6-7 WEEKS. IN 2008 - PATIENT PRESENTED TO THE EMERGENCY DEPARTMENT WITH COMPLAINTS OF INCREASED PAIN. THIS PAIN WAS DESCRIBED AS DIFFERENT THAN WHAT THE PATIENT HAD EXPERIENCED PRIOR, AND HAD GOTTEN WORSE OVER THE LAST 2 WEEKS. PATIENT WAS ADMITTED TO THE HOSPITAL WITH SLIGHTLY ELEVATED WBCS, AFEBRILE. AT ABOUT 2 DAYS LATER - PATIENT'S TEMPERATURE HAS RANGED FROM 99.9 F TO 100.5 F WITH A WBC COUNT OF 13,000. A NEW CT TAKEN INDICATES A FLUID COLLECTION NEAR ON OR NEAR THE LEFT SIDE OF THE MESH AREA, AND THE MESH DOES NOT APPEAR TO BE ATTACHED TO THE CHEST WALL. MESH WAS EXPLANTED. AT ABOUT ONE WEEK LATER - PATIENT WAS DISCHARGED FROM HOSPITAL AND IS DOING WELL POST OPERATIVELY. AT ABOUT TWO WEEKS LATER - SURGEON REPORTED THE PT IS "DOING MUCH BETTER POST-OPERATIVELY THAN WE WOULD HAVE EXPECTED".

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MESH - COMPOSIX KUGEL FTL DAVOL INC., SUB. C.R. BARD, INC. NA 43JND288

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R