BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MESH - COMPOSIX KUGEL

    MDR report key: 2831020 · Received November 1, 2012

    Report

    Report Number
    1213643-2012-00751
    Event Type
    Injury
    Date Received
    November 1, 2012
    Date of Event
    December 3, 2004
    Report Date
    March 9, 2009
    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

    THE DEVICE ASSOCIATED WITH THIS EVENT WAS ORIGINALLY REPORTED TO DAVOL AS A RECALL COMPOSIX KUGEL MESH; THEREFORE, DAVOL ORIGINALLY REPORTED THIS EVENT TO THE FDA IN ACCORDANCE WITH RAE (B)(4). SUBSEQUENTLY, DAVOL HAS RECEIVED ADDITIONAL EVENT INFO INDICATING THAT THE ASSOCIATED EVENT DEVICE IS NOT A RECALLED COMPOSIX KUGEL MESH; THEREFORE WE ARE SUBMITTING THIS MDR BASED ON THE ADDITIONAL INFO RECEIVED. BASED ON THE INFO PROVIDED, NO DEFINITIVE CONCLUSIONS CAN BE MADE. THE PT HAS CO-MORBIDITIES INCLUDING MORBID OBESITY, AND HAD GASTRIC BYPASS 10 MONTHS AFTER HERNIA REPAIR. AT THAT TIME THE DEFECT WAS NOTED BY THE SURGEON, BUT WAS NOT REPAIRED THE INFO PROVIDED INDICATES THAT THE PT DEVELOPED AND WAS TREATED FOR ADHESIONS AND FISTULA, WHICH ARE KNOWN ADVERSE EVENTS LISTED IN THE IFU. A MFG REVIEW WAS PERFORMED, AND FOUND NO EVIDENCE OF A MFG RELATED CAUSE FOR THE ALLEGED EVENT. THERE IS NO INDICATION OF DEFECTIVE MESH, AND NO PRODUCT HAS BEEN RETURNED. IF ANY ADDITIONAL INFO IS OBTAINED, A FOLLOW-UP MDR WILL BE SUBMITTED.

    Description of Event or Problem · 1

    THE FOLLOWING IS BASED ON THE MEDICAL RECORDS PROVIDED BY THE PT'S ATTORNEY: (B)(6) 2002 - PT UNDERWENT REPAIR OF RE-RECURRENT VENTRAL INCISIONAL HERNIA WITH IMPLANT OF COMPOSIX KUGEL MESH. LYSIS OF ADHESIONS WAS PERFORMED. PT WAS NOTED TO HAVE A SOLID ABDOMEN FROM SMALL BOWEL INTRA-ADHESIVE DISEASE. ON (B)(6) 2002 - PT UNDERWENT ROUX-EN-Y GASTRIC BYPASS. DURING LYSIS OF ADHESIONS, SEROSAL TEARS ALONG THE SMALL BOWEL WERE SUTURED. "ONCE WE HAD TAKEN DOWN ALL THE ADHESIONS TO THE ANTERIOR ABDOMINAL WALL WE COULD SEE THAT THERE WERE SEVERAL LARGE PIECES OR SMALL PIECES OF CRUMPLED UP MESH IN THE LOWER PORTION OF MIDLINE INCISION THAT WERE NOT COVERING SEVERAL SMALL DEFECTS. SMALL BOWEL WAS DENSELY ADHERENT TO THIS AREA AND THIS WAS WHERE WE HAD OUR SEROSAL TEARS." "THE PRIOR INCISIONAL HERNIA DONE WITH MESH HAD ESSENTIALLY BROKEN DOWN WITH MULTIPLE DEFECTS; THERE WERE LEFT ALONE." ON (B)(6) 2002 - PT DEVELOPED A WOUND INFECTION, WITHOUT ANY DRAINAGE. ON (B)(6) 2002 - PT HAS PURULENCE AT THE BASE OF THE WOUND. ON (B)(6) 2004 - PT NOTED HERNIA "BURST", BEGAN LEAKING BLOODY, FOUL-SMELLING FLUID. FIRM MASS IN SUPRAUMBILICAL AREA WITH OLD SCAR WITH SEROSANGUINEOUS, FECULENT-SMELLING FLUID. ON (B)(6) 2004 - PT UNDERWENT AN EXPLORATORY LAPAROTOMY. A SEGMENT OF SMALL BOWEL WAS INCORPORATED INTO MESH WITH ENTEROCUTANEOUS FISTULA CREATING A SMALL BOWEL OBSTRUCTION. ADHESIONS WERE LYSED, A SMALL BOWEL RESECTION WAS PERFORMED, AND COMPOSIX KUGEL MESH EXPLANTED. THERE WAS MINIMAL TO NO CONTAMINATION OF THE BOWEL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MESH - COMPOSIX KUGEL FTL DAVOL INC., SUB. C.R. BARD, INC. NA 4EILD148

    Patients

    Seq Age Sex Outcome Treatment
    1 49 YR Required Intervention