BEUDAMED
    FDA Adverse Event Death Summary report: N

    MESH-COMPOSIX KUGEL

    MDR report key: 2544702 · Received April 17, 2012

    Report

    Report Number
    1213643-2012-00289
    Event Type
    Death
    Date Received
    April 17, 2012
    Date of Event
    January 12, 2012
    Report Date
    March 19, 2012
    Manufacturer
    DAVOL INC.
    Product Code
    FTL
    PMA / PMN Number
    K003323
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    ATTORNEY

    Narratives

    Additional Manufacturer Narrative · 1

    WE HAVE CONTACTED THE INITIAL REPORTED TO REQUEST ADD'L INFO AND TO REQUEST RETURN OF THE DEVICE FOR EVAL. THIS MDR INCLUDES ALL PT, EVENT AND DEVICE INFO DAVOL HAS RECEIVED TO DATE. AT THIS TIME THE DEGREE TO WHICH THE DEVICE MAY HAVE CAUSE OR CONTRIBUTED TO TE REPORTED EVENT CANNOT BE DETERMINED. TO DATE, MEDICAL RECORDS HAVE NOT BEEN PROVIDED. THE ATTORNEY ALLEGES THE PT DEVELOPED AN INFECTION WHICH REQUIRED REMOVAL OF THE COMPOSIX KUGEL MESH. THE WARNING SECTIONS OF THE IFU STATES "IF AN INFECTION DEVELOPS, TREAT THE INFECTION AGGRESSIVELY. THE PROSTHESIS MAY NOT HAVE TO BE REMOVED. AN UNRESOLVED INFECTION, HOWEVER, MAY REQUIRE REMOVAL OF THE PROSTHESIS." ADDITIONALLY, A LOT NUMBER WAS NOT PROVIDED, THEREFORE, A MFG REVIEW IS NOT POSSIBLE AND THE SAMPLE WAS NOT RETURNED FOR EVAL. THE ATTORNEY ALSO ALLEGES THE PT SUFFERED INJURIES INCLUDING A BOWEL PERFORATION AND FISTULA. CURRENTLY, MEDICAL RECORDS, AUTOPSY REPORT AND DEATH CERTIFICATE HAVEN NOT BEEN PROVIDED AND THERE IS NO WAY TO DETERMINE THE CAUSE OF THE ALLEGED BOWEL PERFORATION. A SUPPLEMENTAL REPORT WILL BE SUBMITTED IF/WHEN ADD'L INFO IS PROVIDED; HOWEVER, WITH THE CURRENTLY AVAILABLE INFO, NO CONCLUSION CAN BE DRAWN.

    Description of Event or Problem · 1

    THE FOLLOWING WAS REPORTED BY THE ATTORNEY FOR THE PT: NI/NI/NI THE PT UNDERWENT VENTRAL HERNIA REPAIR WITH COMPOSIX KUGEL. ON (B)(6) 2010, THE PT DEVELOPED SERIOUS INFECTIOUS COMPLICATIONS NECESSITATING FURTHER SURGERY. THE COMPOSIX KUGEL MESH WAS WRAPPED AROUND HER INTERNAL ORGANS CAUSING SEVERE AND PERMANENT DAMAGE AND INJURY. THE MESH WAS REMOVED. ON (B)(6) 2012, THE PT CONTINUED TO SUFFER EXTREME COMPLICATIONS, PAIN, DISFIGUREMENT AND LOSS OF FUNCTION AND WAS ADMITTED TO THE HOSPITAL. ON (B)(6) 2012, THE PT EXPIRED. THE PT'S CAUSE OF DEATH WAS NOTED AS SEPSIS SECONDARY TO ACUTE PERITONITIS. THE ATTORNEY ALLEGES THE PT SUFFERED SUCH INJURIES AS BOWEL PERFORATIONS, INTESTINAL FISTULA AND INFECTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MESH-COMPOSIX KUGEL FTL DAVOL INC. NA NI

    Patients

    Seq Age Sex Outcome Treatment
    1 NI Death| H| R| S