BEUDAMED
    FDA Adverse Event Death Summary report: N

    MESH - COMPOSIX KUGEL

    MDR report key: 4629701 · Received March 20, 2015

    Report

    Report Number
    1213643-2015-00079
    Event Type
    Death
    Date Received
    March 20, 2015
    Date of Event
    April 16, 2014
    Report Date
    February 27, 2015
    Manufacturer
    DAVOL INC., SUB. C.R. BARD, INC.
    Product Code
    FTL
    PMA / PMN Number
    K003323
    Removal / Correction Number
    Z-0525-06
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    RI, US
    Reporter Occupation
    ATTORNEY

    Narratives

    Additional Manufacturer Narrative · 1

    CURRENTLY, IT IS UNK WHETHER THE DEVICE MAY HAVE CAUSED OR CONTRIBUTED TO THE REPORTED EVENT. THE PT'S ATTY HAS NOT PROVIDED MEDICAL RECORDS. CATALOG NUMBER 0010207 HAS BEEN USED BASED ON THE ITEM DESCRIPTION GIVEN THE IN ATTY'S REPORT. IT IS ALLEGED THAT THE PT WAS TREATED FOR INFECTION, FISTULA, EROSION ADHESIONS WHICH ARE ALL LISTED AS POTENTIAL EFFECTS OF FAILURE IN THE INSTRUCTIONS-FOR-USE. WITHOUT A LOT NUMBER A REVIEW OF THE MFG RECORDS COULD NOT BE CONDUCTED. ADDITIONALLY, NO PROD WAS RETURNED FOR EVAL. WITH THE CURRENTLY AVAILABLE INFO, NO CONCLUSION CAN BE DRAWN. IF ADD'L EVENT AND/OR EVAL INFO IS OBTAINED, A F/U MDR WILL BE SUBMITTED.

    Description of Event or Problem · 1

    THE FOLLOWING WAS REPORTED TO DAVOL BY THE PT'S ATTORNEY: ON (B)(6) 2015 - PT WAS IMPLANTED WITH A BARD/DAVOL COMPOSIX KUGEL EXTRA LARGE OVAL MESH DURING A VENTRAL HERNIA REPAIR PROCEDURE. ON (B)(6) 2013 - THE PT BECAME ILL AND DEVELOPED AN AREA OF INCREASED POINT TENDERNESS IN THE MID PORTION OF THE PREVIOUS ABDOMINAL WOUND. ON (B)(6) 2014 - PT PRESENTED TO THE HOSPITAL WITH AN ABDOMINAL WOUND WALL ABSCESS. THE SURGEON DISCOVERED THE UNDERLYING MESH WAS EXPOSED. ON (B)(6) 2014 - THE PT UNDERWENT PROCEDURES FOR THE ABDOMINAL WOUND INFECTION AND COLOCUTANEOUS FISTULA, INCLUDING EXCISION OF THE INFECTED MESH. ON (B)(6) 2014 - PT UNDERWENT A SURGICAL PROCEDURE DUE TO THE MESH EROSION THROUGH THE BOWEL WALL. THE MESH WAS EXCISED AND A COLONIC STENT WAS PLACED. ON (B)(6) 2014 - THE VISIBLE PLASTIC MESH REMNANTS WERE DEBRIDED. THE MESH WAS DENSELY ADHERENT TO THE BOWEL. THE ATTY'S REPORT ALLEGES THE PT SUFFERED INFECTION, FISTULA, MESH EROSION, EXCISION OF MESH AND ADHESIONS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    190515 MESH - COMPOSIX KUGEL SURGICAL MESH FTL DAVOL INC., SUB. C.R. BARD, INC. NA 43FOD331

    Patients

    Seq Age Sex Outcome Treatment
    1 46 YR Death| H| R| S