BEUDAMED
    FDA Adverse Event Death Summary report: N

    MESH - COMPOSIX KUGEL

    MDR report key: 1739270 · Received June 25, 2010

    Report

    Report Number
    1213643-2010-00313
    Event Type
    Death
    Date Received
    June 25, 2010
    Date of Event
    November 7, 2007
    Report Date
    May 28, 2010
    Manufacturer
    DAVOL INC., SUB. C.R. BARD, INC.
    Product Code
    FTL
    PMA / PMN Number
    K003323
    Removal / Correction Number
    Z-0760-06
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE COMPLAINANT REPORTED THAT TWO MESHES WERE IMPLANTED AND WAS A DEVICE CATALOG NUMBER 0010202 OR 0010102. SEE MDR NUMBER 1213643-2010-00314 FOR INFO RELATED TO DEVICE CATALOG NUMBER 0010202. WE HAVE CONTACTED THE INITIAL REPORTER TO REQUEST ADD'L PT MEDICAL INFO/RECORDS, COPY OF A DEATH CERTIFICATE/AUTOPSY REPORT, AND TO REQUEST RETURN OF THE DEVICE FOR EVAL. THIS MDR INCLUDES ALL PT, EVENT AND DEVICE INFO DAVOL HAS RECEIVED TO DATE. A DHR REVIEW HAS NOT BEEN CONDUCTED, SINCE NO LOT NUMBER HAS BEEN PROVIDED. BASED ON THE PROVIDED MEDICAL RECORDS, IT IS UNK WHAT THE PT'S CLINICAL COURSE WAS FROM THE DATE OF IMPLANT OF (B) (6) 2001 TO THE HOSPITALIZATION DATE OF (B) (6) 2006, THEREFORE, WE ARE UNABLE TO DETERMINE THE POSSIBLE CAUSE OF PT'S FISTULA DEVELOPMENT. DAVOL HAS NOT RECEIVED A COPY OF THE DEATH CERTIFICATE, AUTOPSY REPORT, OR ANY MEDICAL RECORDS AFTER (B) (6) 2007 EXPLAINING THE CLINICAL COURSE OF EVENTS THE PT UNDERWENT, THEREFORE, NO CONCLUSION CAN BE DRAWN.

    Description of Event or Problem · 1

    ATTORNEY REPORTED: ON (B) (6) 2001 - PT WAS IMPLANTED WITH TWO UNITS OF COMPOSIX KUGEL LARGE OVAL MESH TO REPAIR A VENTRAL HERNIA, AND THE CATALOG NUMBERS ARE A 0010202 OR 0010102. AFTER IMPLANTATION, THE COMPOSIX KUGEL MESH RINGS BROKE AND THE MESH ERODED INTO THE SIGMOID COLON, CREATING A COLOCUTANEOUS FISTULA WHICH CAUSED PT GREAT PAIN AND ILLNESS. ON (B) (6) 2007 - PT WAS NOTED TO HAVE MULTIPLE FISTULOUS TRACTS ON THE LOWER ABDOMINAL WALL WITH FECULENT DRAINAGE FROM ALL SITES, AND A CONSEQUENT DEEP VEIN THROMBOSIS IN HER RIGHT LEG. ON (B) (6) 2007 - PT UNDERWENT CREATION OF A TOTALLY DIVERTING PROXIMAL TRANSVERSE LOOP COLOSTOMY WITH PARTIAL REMOVAL OF THE TWO MESHES AND RINGS AS FAR AS POSSIBLE WITHOUT ENLARGING THE FISTULOUS OPENING CAUSED BY THE FAILED MESHES. THE MESH RINGS WERE NOTED AT PATHOLOGY TO BE IN THREE PIECES WITH FRAGMENTED ENDS, FROM 7CM TO 7.5CM IN LENGTH AND MEASURING UP TO 1 CM IN ARCH DIAMETER. ON (B) (6) 2007 - PT STILL HAD FECULENT DRAINAGE FROM HER MULTIPLE ABDOMINAL WOUNDS. IN (B) (6) 2007 - PT DEVELOPED SEVERE BLOOD INFECTION IN CONJUNCTION WITH THE TPN (TOTAL PARENTERAL NUTRITION) INFUSION PUMP NECESSITATED BY THE SEPTIC CONDITION CREATED BY THE FECULENT DRAINAGE FROM HER KUGEL MESH INJURIES. ON (B) (6) 2007 - PT DIED OF CARDIOPULMONARY ARREST DUE TO SEPSIS, AS A CONSEQUENCE OF THE FOUR NON-HEALING ABDOMINAL FISTULAS CAUSED BY HER KUGEL MESHES.

    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 85 YR Death| H| L| R