BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BARD FLAT MESH

    MDR report key: 2773335 · Received September 27, 2012

    Report

    Report Number
    1213643-2012-00628
    Event Type
    Injury
    Date Received
    September 27, 2012
    Date of Event
    August 10, 2007
    Report Date
    May 18, 2009
    Manufacturer
    DAVOL INC., SUB. C.R. BARD, INC.
    Product Code
    FTL
    PMA / PMN Number
    PREAMENDMENT
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WV, US
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    INITIALLY, ONE EVENT WAS PREVIOUSLY REPORTED BY THE PTS' ATTORNEY. HOWEVER, REVIEW OF THE MEDICAL RECORDS SHOWED THERE TO BE ADDITIONAL IMPLANTS AND POSTOPERATIVE EVENTS. BASED ON THE INFO AVAILABLE AT THIS TIME, NO DEFINITIVE CONCLUSIONS CAN BE MADE. THIS IS AN OBESE PT WHO HAS UNDERGONE MULTIPLE ABDOMINAL SURGERIES. THE MEDICAL RECORDS INDICATE THAT THE PT WAS TREATED FOR ADHESIONS AND FISTULA FORMATION BOTH OF WHICH ARE KNOWN POSSIBLE ADVERSE REACTIONS LISTED IN THE IFU. 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 REQUIRE REMOVAL OF THE PROSTHESIS." ADDITIONALLY, NO SAMPLE WAS RETURNED FOR EVAL. IF ADDITIONAL EVENT AND/OR EVAL INFO IS OBTAINED, A F/U MDR WILL BE SUBMITTED. SEE 1213643-2012-00629 FOR INFO RELATED TO THE FLAT MESH IMPLANTED ON (B)(6) 2000. SEE MDR 1213643-2012-00630 FOR INFO RELATED TO THE COMPOSIX E/X MESH IMPLANTED ON (B)(6) 2003. SEE MDR 1213643-2008-00572 FOR INFO RELATED TO THE COMPOSIX KUGEL MESH IMPLANTED ON (B)(6) 2006.

    Description of Event or Problem · 1

    THE EVENT AS DESCRIBED ON THE MAUDE REPORT INCLUDED, INFECTION, BOWEL RESECTION, FISTULA, AND EXPLANT. THE FOLLOWING IS BASED ON THE MEDICAL RECORDS PROVIDED BY THE PT: (B)(6) 1999 - REPAIR OF INCISIONAL HERNIA WITH FLAT MESH. ON (B)(6) 2000 - REPAIR OF RECURRENT INCISIONAL HERNIA WITH FLAT MESH. ON (B)(6) 2003 - REPAIR OF RECURRENT INCISIONAL HERNIA WITH COMPOSIX E/X MESH. PREVIOUSLY PLACED FLAT MESH WAS NOTED TO BE ADHERED TO THE BOWEL. TO SPARE THE BOWEL FROM INJURY THESE ADHESIONS WERE LEFT ATTACHED TO THE BOWEL. ON (B)(6) 2006 - REPAIR OF CHRONICALLY INCARCERATED LLQ VENTRAL HERNIA WITH COMPOSIX KUGEL MESH. DENSE INTA-ABDOMINAL ADHESIONS WERE NOTED. ON (B)(6) 2007 - EXCISION OF INFECTED MESH WITH PLACEMENT OF A COLLAMEND GRAFT. THE PT WAS NOTED TO HAVE A PHLEGMON WITH A PUS FILLED CAVITY AND AN ENTERCUTANEOUS FISTULA. THE INVOLVED BOWEL WAS RESECTED WITH PRIMARY SIDE TO SIDE FUNCTIONAL END TO END ANASTOMOSIS. (NOTE: ALL PREVIOUSLY PLACED BARD MESH WAS EXCISED AT THIS TIME.)

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BARD FLAT MESH FTL DAVOL INC., SUB. C.R. BARD, INC. NA 43FJD059

    Patients

    Seq Age Sex Outcome Treatment
    1 31 YR Required Intervention