BEUDAMED
    FDA Adverse Event Death Summary report: N

    MESH-COMPOSIX KUGEL

    MDR report key: 1063283 · Received June 19, 2008

    Report

    Report Number
    1213643-2008-00336
    Event Type
    Death
    Date Received
    June 19, 2008
    Date of Event
    May 23, 2006
    Report Date
    May 20, 2008
    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

    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 ADD'L INFO HAS NOT BEEN RESPONDED TO. NO CONCLUSION CAN BE DRAWN AT THIS TIME. ADD'L 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 EVAL OR ADD'L INFO BECOMES AVAILABLE.

    Description of Event or Problem · 1

    ATTORNEY REPORTED: IN 2003 - PT HAD A VENTRAL INCISIONAL HERNIA REPAIRED. A LARGE CIRCLE COMPOSIX KUGEL PATCH WAS IMPLANTED INTO THE PT AT THIS TIME. IN 2006 - PT DEVELOPED A BOWEL OBSTRUCTION ASSOCIATED WITH NAUSEA, VOMITING, ABDOMINAL PAIN, ABDOMINAL DISTENTION AND FAILURE TO HAVE BOWEL MOVEMENTS. ON THE SAME MONTH - PT WAS TAKEN INTO SURGERY FOR REPAIR OF THE SMALL BOWEL OBSTRUCTION. DURING SURGERY, IT WAS NOTED THAT THERE WAS SMALL BOWEL DENSELY ADHERENT TO SEVERAL PIECES OF MESH AND WAS DESEROSALIZED, REQUIRING REPAIR. AT THAT TIME, THE PREVIOUSLY PLACED KUGEL PATCH WAS REMOVED DUE TO THE NATURE BY WHICH IT HAD ADHERED TO AND DESEROSALIZED THE BOWEL. THE PT'S CONDITION NEVER IMPROVED AFTER THE KUGEL PATCH REMOVAL, REPAIR PROCEDURES AND IRRIGATION OF THE WOUND. THE PT REMAINED UNSTABLE UNTIL A WEEK LATER, WHEN SHE BEGUN UNRESPONSIVENESS. PT DIED THAT DAY. PER THE ATTORNEY, THE CAUSE OF DEATH WAS SMALL BOWEL OBSTRUCTION SECONDARY TO INCARCERATED VENTRAL HERNIA REPAIRED AND POSTOPERATIVE SEPSIS DEVELOPING WITH PNEUMONIA AND RESPIRATORY FAILURE.

    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