BEUDAMED
    FDA Adverse Event Death Summary report: N

    MESH-COMPOSIX KUGEL

    MDR report key: 1305318 · Received February 3, 2009

    Report

    Report Number
    1213643-2009-00084
    Event Type
    Death
    Date Received
    February 3, 2009
    Date of Event
    January 19, 2006
    Report Date
    January 13, 2009
    Manufacturer
    DAVOL INC., SUB. C.R. BARD, INC.
    Product Code
    FTL
    PMA / PMN Number
    K003323
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    RI, US
    Reporter Occupation
    ATTORNEY

    Narratives

    Additional Manufacturer Narrative · 1

    NOTE: DATE OF DEATH IS REPORTED TO BE 2006 WITH THE DATE OF EXPLANT AS 2006. BASED ON THE INFO PROVIDED, WE ARE UNABLE TO DETERMINE WHICH OF THESE DATES ARE IN ERROR, THEREFORE, WE ARE REPORTING THE DATES AS PROVIDED. CURRENTLY, IT IS UNK WHETHER OR NOT THE DEVICE MAY HAVE CAUSED OR CONTRIBUTED TO THE EVENT, AS NO PRODUCT HAS BEEN RETURNED OR REQUEST FOR ADDITIONAL INFO HAS NOT BEEN RESPONDED TO. NO CONCLUSION CAN BE DRAWN AT THIS TIME. ADDITIONAL INFO INCLUDING PT INFO, COPIES OF MEDICAL INFO/RECORDS AND DEATH CERTIFICATE/AUTOPSY REPORT HAVE BEEN REQUESTED. A DHR REVIEW HAS NOT BEEN CONDUCTED, SINCE NO SPECIFIC PRODUCT CODE OR LOT NUMBER HAVE BEEN PROVIDED. WE WILL SUBMIT A FOLLOW UP REPORT WHEN/IF PRODUCT IS RETURNED FOR EVALUATION OR ADDITIONAL INFO BECOMES AVAILABLE.

    Description of Event or Problem · 1

    ATTORNEY REPORTED: IN 2005 -- THE PT UNDERWENT AN INCISIONAL UMBILICAL HERNIA REPAIR WITH PLACEMENT OF A COMPOSIX KUGEL MESH PATCH. AFTER THE IMPLANT OF THE CK MESH PATCH, THE PT BEGAN SUFFERING CONSIDERABLE ABDOMINAL PAIN. IN 2006 -- THE PT WAS EXAMINED DUE TO INCREASED ABDOMINAL PAIN AND COMPLICATIONS AND SHOWED EVIDENCE OF SERIOUS BOWEL OBSTRUCTION. IN THE NEXT DAY, THE PT UNDERWENT SURGERY IN WHICH THE MESH WAS NOTED TO HAVE OPENED SUCH THAT A KNUCKLE OF BOWEL HAD PENETRATED THROUGH A 3 MM OPENING IN THE MESH PATCH. THE OPENING IN THE PATCH WAS CAUSING THE OBSTRUCTION AND ABDOMINAL DISTRESS. THE MESH PATCH WAS REMOVED AND THE WOUND WAS CLOSED WITH ANOTHER BRAND OF MESH HERNIA PATCH. WHILE STILL HOSPITALIZED AND IN RECOVERY, THE PT'S CONDITION DETERIORATED AND HE ENTERED SEPTIC SHOCK. THE PT WAS ADMITTED TO THE ICU. ANOTHER EXPLORATORY SURGERY WAS PERFORMED IN AN ATTEMPT TO ISOLATE AND TREAT THE SEPSIS. OVER THE NEXT WEEK, THE PT REMAINED IN CRITICAL CONDITION AND ON A VENTILATOR. THE PT BEGAN SUFFERING FROM KIDNEY AND ORGAN FAILURE AND BEGAN EXPERIENCING SEIZURES, FEVERS AND DISTRESS. IN 2006 -- THE PT'S EEG SHOWED NO BRAIN ACTIVITY AND HE PRONOUNCED DEAD.

    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 Death| H