BEUDAMED
    FDA Adverse Event Injury Summary report: N

    COMPOSIX MESH EX

    MDR report key: 2585446 · Received May 17, 2012

    Report

    Report Number
    1213643-2012-00422
    Event Type
    Injury
    Date Received
    May 17, 2012
    Date of Event
    December 15, 2010
    Report Date
    February 9, 2012
    Manufacturer
    DAVOL INC., SUB. C.R. BARD, INC.
    Product Code
    FTL
    PMA / PMN Number
    K002684
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    ATTORNEY

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE ASSOCIATED WITH THIS EVENT WAS ORIGINALLY REPORTED TO DAVOL AS A RECALLED COMPOSIX KUGEL MESH; THEREFORE, DAVOL ORIGINALLY REPORTED THIS EVENT TO THE FDA IN ACCORDANCE WITH (B)(4). SUBSEQUENTLY, DAVOL HAS RECEIVED ADD¿L EVENT INFO INDICATING THAT THE ASSOCIATED EVENT DEVICE IS NOT A RECALLED COMPOSIX KUGEL MESH; THEREFORE WE ARE SUBMITTING THIS MDR BASED ON THE ADD¿L INFO RECEIVED. BASED ON THE INFO AVAILABLE AT THIS TIME, NO DEFINITIVE CONCLUSION CAN BE MADE. THE COMPOSIX EX MESH CAN BE TAILORED WITHOUT SEPARATION OF THE TWO LAYERS BY TRIMMING OUTSIDE OF THE STITCHING. THE HOSP DISCHARGE SUMMARY DATED (B)(6) 2011, NOTED INFECTED ABDOMINAL MESH IN ADDITION TO LLQ HEMATOMA, NECROTIC ABDOMINAL WALL, LOSS OF ABDOMINAL DOMAIN. ENTEROCUTANEOUS FISTULA. UTI, AND DECOMPENSATION. DURING THIS HOSPITAL STAY THE PT ALSO UNDERWENT HERNIA REPAIR WITH A NON-BARD MESH. THE MEDICAL RECORDS INDICATE THAT THE PT WAS TREATED FOR HEMATOMA AND FISTULA FORMATION BOTH OF WHICH ARE KNOWN POSSIBLE ADVERSE REACTIONS LISTED IN THE IFU. IT WAS ALSO INDICATED THAT THE PT WAS TREATED FOR AN INFECTION. WHILE THERE IS NO INDICATION THAT THE MESH WAS THE SOURCE OF THE REPORTED INFECTION, THE WARNING SECTION 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 NOT HAVE TO BE REMOVED. AN UNRESOLVED INFECTION, HOWEVER, MAY REQUIRE REMOVAL OF THE PROSTHESIS.¿ THERE WAS NO LOT NUMBER INCLUDED IN THE MEDICAL RECORDS PROVIDED; THEREFORE A REVIEW OF THE MFG RECORDS COULD NOT BE CONDUCTED. ADDITIONALLY, NO SAMPLE WAS RETURNED FOR EVAL. IF ADD¿L EVENT AND/OR EVAL INFO IS OBTAINED, A FOLLOW UP MDR WILL BE SUBMITTED.

    Description of Event or Problem · 1

    THE INITIAL ATTORNEY REPORT ALLEGED BOWEL INJURY, DISABILITY, INJURY PAIN/SUFFERING, AND EXPLANT DUE TO A DEFECTIVE MESH. THE FOLLOWING IS BASED ON THE MEDICAL RECORDS PROVIDED BY THE PT¿S ATTORNEY: (B)(6) 2004 ¿ LAPAROSCOPIC REPAIR OF A PERISTOMAL HERNIA AND AN INCISIONAL VENTRAL HERNIA WITH COMPOSIX E/X MESH. THE MESH USED TO REPAIR THE PARISTOMAL HERNIA WAS INCISED ALONG ITS VERTICAL AXIS IN THE MIDLINE UP THE MIDDLE, AND CIRCLE WAS EXCISED SO THAT THE MESH WOULD GO AROUND THE COLON. A CHOLECYSTECTOMY WAS ALSO PERFORMED. (NOTE: SEE MDR 1213646-2012-00147 FOR INFO RELATED TO THE COMPOSIX E/X MESH USED TO REPAIR THE VENTRAL HERNIA). ON (B)(6) 2010 - EXPLORATORY LAPAROTOMY AND INCISION AND DRAINAGE OF AN ABDOMINAL WALL ABSCESS. ON (B)(6) 2010 ¿ INFECTIOUS DISEASE CONSULT, RETAINED INFECTED MESH WITH A POLYMICROBIAL INFECTION. IT MAY BE DIFFICULT TO ERADICATE THE INFECTION FROM THIS SITE. THERE IS CONCERN FOR A POSSIBLE ENTERCUTANEOUS FISTULA BUT THIS DOES NOT APPEAR TO BE THE CASE AT PRESENT. ON (B)(6) 2010 - OFFICE VISITS FOR WOUND CARE SHOW DIAGNOSIS OF CELLULITIS OF TRUNK WITH RLQ. WOUND HEALING WAS ACHIEVED. (B)(6) 2010 ¿ PRESENTS TO THE EMERGENCY ROOM WITH PERIUMBILICAL AND ABDOMINAL PAIN WITH FEVER. THE DIAGNOSIS WAS ANTERIOR ABDOMINAL WALL ABSCESS. (B)(6) 2010- ADMITTED FOR ABDOMINAL PARACENTESIS, WITH IR GUIDED PIGTAIL DRAIN PLACEMENT AND ANTIBIOTIC TREATMENT. ON (B)(6) 2010 ¿ EXCISION OF INFECTED COMPOSIX E/X MESH. BOTH OF THE PREVIOUSLY PLACED COMPOSIX E/X MESH WERE REMOVED. ON (B)(6) 2010 - (B)(6) 2011 - MULTIPLE PROCEDURES EVERY OTHER DAY FOR WIDE DEBRIDEMENT OF ABD WALL, SKIN, FAT, MUSCLE AND FASCIA, TAKEDOWN OF ENTERATMOSPHERIC FISTULAS. BOWEL AND COLON RESECTION. SKIN GRAFTING, WOUND VAC PLACEMENT AND CHANGES. THE ABDOMINAL WOUND WAS LEFT OPEN AFTER EACH PROCEDURE. AN ENTERIC DRAINAGE WAS NOTED WITHIN THE OPEN CAVITY THIS WAS DUE TO AN ENTEROTOMY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 COMPOSIX MESH EX FTL DAVOL INC., SUB. C.R. BARD, INC. NA NI

    Patients

    Seq Age Sex Outcome Treatment
    1 61 YR Hospitalization| S