BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BARD PERFIX PLUG

    MDR report key: 2233998 · Received August 31, 2011

    Report

    Report Number
    1213643-2011-00409
    Event Type
    Injury
    Date Received
    August 31, 2011
    Date of Event
    December 13, 2006
    Report Date
    June 21, 2010
    Manufacturer
    DAVOL INC., SUB. C.R. BARD, INC.
    Product Code
    FTL
    PMA / PMN Number
    K922916
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    INITIALLY, ONE EVENT WAS REPORTED BY THE PATIENTS' ATTORNEY. HOWEVER, REVIEW OF THE MEDICAL RECORDS SHOWED THERE TO BE ADDITIONAL IMPLANTS. BASED ON MEDICAL RECORD REVIEW A MORBIDLY OBESE PATIENT WITH A HISTORY OF DIABETES UNDERWENT REPAIR OF AN INCISIONAL HERNIA WITH COMPOSIX KUGEL MESH ON (B)(6) 2003. ON (B)(6) 2004, IT IS REPORTED THAT THE PATIENT UNDERWENT EXCISION OF THE COMPOSIX KUGEL MESH AND RECURRENT INCISIONAL HERNIA REPAIR WITH COMPOSIX KUGEL MESH. THE MEDICAL RECORDS INDICATE THAT THE PATIENT UNDERWENT RECURRENT INCISIONAL HERNIA REPAIR AND A PANNICULECTOMY ON (B)(6) 2006. THE PREVIOUSLY PLACED COMPOSIX KUGEL MESH WAS NOTED TO HAVE PULLED LOOSE INFERIORLY, AND THAT THE HERNIAL SAC WAS REDUCED BACK INSIDE THE ABDOMINAL CAVITY, AND TWO PERFIX PLUGS WERE PLACED FOR REINFORCEMENT. THE MEDICAL RECORDS REPORT THAT ON (B)(6) 2006, THE PATIENT UNDERWENT EXCISION OF THE TWO PERFIX PLUGS, WOULD DEBRIDEMENT, AND DRAINAGE OF INFECTED WOUND HEMATOMA. IT WAS NOTED THAT THE ABDOMINAL WALL DEFECT WAS REINFORCED WITH NON-BARD MESH. IT WAS REPORTED THAT TISSUE SAMPLES SENT FOR CULTURE SHOWED CORYNEBACTERIUM SPECIES. THE MEDICAL RECORDS REPORT THAT SUBSEQUENTLY, THE PATIENT DEVELOPED A SINUS TRACT WITH DRAINAGE. ON (B)(6) 2007, IT IS REPORTED THAT THE PATIENT UNDERWENT EXPLORATORY LAPAROTOMY, EXCISION OF INFECTED COMPOSIX KUGEL MESH, REPAIR OF RECURRENT INCISIONAL HERNIA WITH NON-BARD MESH, AND PLACEMENT OF WOUND VAC. ON (B)(6) 2007, IT WAS REPORTED THAT A WOUND CULTURE SHOWED (B)(6). BASED ON THE INFORMATION PROVIDED, IT IS UNKNOWN WHETHER THE DEVICE MAY HAVE CAUSED OR CONTRIBUTED TO THE REPORTED EVENT. THE MEDICAL RECORDS INDICATED THAT THE PATIENT WAS TREATED FOR RECURRENCE AND HEMATOMA BOTH OF WHICH ARE KNOWN POSSIBLE ADVERSE REACTIONS LISTED IN THE IFU. THE INFORMATION PROVIDED INDICATED THAT THE PATIENT WAS TREATED FOR AN 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." NO CONCLUSION CAN BE DRAWN AT THIS TIME. ADDITIONALLY, NO SAMPLE HAS BEEN RETURNED FOR EVALUATION. SEE MDR 1213643-2011-00408 FOR INFORMATION RELATED TO THE OTHER PERFIX PLUG IMPLANTED ON (B)(6) 2006. SEE RAE (B)(4) FOR INFORMATION REGARDING THE COMPOSIX KUGEL MESHES IMPLANTED ON (B)(6) 2003 AND (B)(6) 2004.

    Description of Event or Problem · 1

    BASED ON MEDICAL RECORDS PROVIDED BY THE PATIENT'S ATTORNEY: ON (B)(6) 2003 - PATIENT UNDERWENT REPAIR OF INCISIONAL HERNIA WITH COMPOSIX KUGEL MESH. ON (B)(6) 2004 - PATIENT UNDERWENT EXCISION OF COMPOSIX KUGEL MESH AND RECURRENT INCISIONAL HERNIA REPAIR WITH COMPOSIX KUGEL MESH. ON (B)(6) 2006 - PATIENT UNDERWENT REPAIR OF RECURRENT INCISIONAL HERNIA AND A PANNICULECTOMY. AFTER THE HERNIA SAC WAS REDUCED BACK INSIDE THE ABDOMINAL CAVITY, TWO PERFIX PLUGS WERE PLACED FOR REINFORCEMENT. ON (B)(6) 2006 - PATIENT UNDERWENT WOUND DEBRIDEMENT, DRAINAGE OF INFECTED WOUND HEMATOMA, EXCISION OF TWO PERFIX PLUGS AND REPAIR OF RECURRENT INCISIONAL HERNIA WITH A NON-BARD MESH. ON (B)(6) 2007 - PATIENT UNDERWENT EXPLORATORY LAPAROTOMY, EXCISION OF COMPOSIX KUGEL MESH, RECURRENT INCISIONAL HERNIA REPAIR WITH A NON-BARD MESH, AND PLACEMENT OF WOUND VAC.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BARD PERFIX PLUG FTL DAVOL INC., SUB. C.R. BARD, INC. NA 43BQD167

    Patients

    Seq Age Sex Outcome Treatment
    1 41 YR Required Intervention