BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MESH-COMPOSIX

    MDR report key: 2221266 · Received August 17, 2011

    Report

    Report Number
    1213643-2011-00381
    Event Type
    Injury
    Date Received
    August 17, 2011
    Date of Event
    January 2, 2002
    Report Date
    January 6, 2010
    Manufacturer
    DAVOL INC., SUB. C.R. BARD, INC.
    Product Code
    FTL
    PMA / PMN Number
    K971745
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    INITIALLY, ONE EVENT WAS REPORTED BY THE PTS' ATTORNEY. HOWEVER, REVIEW OF THE MEDICAL RECORDS SHOWED THERE TO BE AN ADDITIONAL IMPLANT. BASED ON MEDICAL RECORD REVIEW A PT WITH A HISTORY OF (B)(6) AND OBESITY UNDERWENT REPAIR OF RECURRENT VENTRAL INCISIONAL HERNIA WITH COMPOSIX MESH ON (B)(6) 2001. THE MEDICAL RECORDS NOTE THAT THE AREA OF THE UMBILICUS WAS ATTENUATED, AND THE UMBILICAL AREA WAS ELLIPSED AND EXCISED. ON (B)(6) 2001 THE PT UNDERWENT EXPLORATION OF ABDOMINAL WOUND. IT WAS NOTED THAT A POCKET OF PURULENT COLLECTION WITH EXPOSED MESH WAS ENCOUNTERED. IT IS UNCLEAR WHETHER A FULL OR PARTIAL EXCISION OF THE COMPOSIX MESH WAS PERFORMED. A NON-BARD GRAFT WAS PLACED. ON (B)(6) 2001 THE PT UNDERWENT REPAIR OF RECURRENT VENTRAL INCISIONAL HERNIA WITH COMPOSIX MESH. ON (B)(6) 2002 THE COMPOSIX MESH THAT WAS IMPLANTED ON (B)(6) 2001 WAS PARTIALLY EXCISED. THE MEDICAL RECORDS NOTE THAT THE PT CONTINUED TO HAVE PROBLEMS ASSOCIATED WITH THE RECURRENT HERNIA, AND WAS INFORMED BY THE MD THAT THE HERNIA COULD NOT BE REPAIRED UNTIL PT HAS A SIGNIFICANT REDUCTION IN WEIGHT. BASED ON THE INFO PROVIDED, IT IS UNK WHETHER THE DEVICE MAY HAVE CAUSED OR CONTRIBUTED TO THE REPORTED EVENT. THE MEDICAL RECORDS INDICATE 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 INFO PROVIDED INDICATED THAT THE PT WAS TREATED FOR RECURRENCE WHICH IS A KNOWN POSSIBLE ADVERSE REACTION LISTED IN THE IFU. ADDITIONALLY, NO SAMPLE WAS RETURNED FOR EVAL. NO CONCLUSION CAN BE DRAWN AT THIS TIME. FOR INFO REGARDING THE COMPOSIX MESH IMPLANTED ON (B)(6) 2001 SEE MDR 1213643-2009-00366.

    Description of Event or Problem · 1

    BASED ON MEDICAL RECORDS PROVIDED BY PT'S ATTORNEY: (B)(6) 2001 - PT UNDERWENT REPAIR OF RECURRENT VENTRAL INCISIONAL HERNIA WITH COMPOSIX MESH. THE AREA OF THE UMBILICUS WAS NOTED TO BE ATTENUATED, AND THE UMBILICAL AREA WAS ELLIPSED AND EXCISED. ON (B)(6) 2011 - PT PRESENTS WITH DRAINAGE OF CLEAR MATERIAL FROM WOUND. CULTURES FROM WOUND DRAINAGE GREW OUT (B)(6), AND E. COLI, AND THAT THE MESH WAS NOTED TO BE EXPOSED. ON (B)(6) 2001 - PT UNDERWENT EXPLORATION OF ABDOMINAL WOUND. A POCKET OF PURULENT COLLECTION WITH EXPOSED MESH WAS ENCOUNTERED. IT IS UNCLEAR WHETHER A FULL OR PARTIAL EXCISION OF THE COMPOSIX MESH WAS PERFORMED. PLACEMENT OF A NON-BARD GRAFT. ON (B)(6) 2001 - PT UNDERWENT REPAIR OF A RECURRENT VENTRAL HERNIA WITH COMPOSIX MESH. ON (B)(6) 2001 - PT UNDERWENT WOUND DEBRIDEMENT. ON (B)(6) 2001 - MEDICAL RECORDS NOTE WOUND DEHISCENCE, WITH EXPOSED MESH. IT IS NOTED THAT THERE IS INSUFFICIENT RECTUS MUSCLE TO TRANSFER AND MOBILIZE TO COVER THE DEFECT. ON (B)(6) 2002 - PT UNDERWENT PARTIAL EXCISION OF COMPOSIX MESH. ON (B)(6) 2002 - PT UNDERWENT WOUND DEBRIDEMENT AND SKIN GRAFT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MESH-COMPOSIX FTL DAVOL INC., SUB. C.R. BARD, INC. NA 43DLD018

    Patients

    Seq Age Sex Outcome Treatment
    1 58 YR Required Intervention