BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BARD FLAT MESH

    MDR report key: 2253881 · Received September 13, 2011

    Report

    Report Number
    1213643-2011-00436
    Event Type
    Injury
    Date Received
    September 13, 2011
    Date of Event
    February 23, 2004
    Report Date
    August 22, 2011
    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
    MN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    INITIALLY, ONE EVENT WAS REPORTED BY THE PT'S ATTORNEY. HOWEVER, REVIEW OF THE MEDICAL RECORDS SHOWED THERE TO BE AN ADD'L IMPLANT. BASED ON MEDICAL RECORD REVIEW A PT SEVERAL YEARS POST EXPLORATORY LAPAROTOMY PRESENTS WITH A LARGE INCISIONAL HERNIA. THE MEDICAL RECORDS INDICATE THAT ON (B)(4) 2002 THE PT UNDERWENT REPAIR OF INCISIONAL HERNIA WITH A BARD FLAT MESH. IT WAS NOTED THAT EXAMINATION OF THE ABDOMEN REVEALED A HYPEREMIC OMENTAL NODULE, WHICH WAS EXCISED. IT WAS REPORTED THAT ON (B)(4) 2004, THE PT UNDERWENT EXCISION OF BARD FLAT MESH AND RECURRENT INCISIONAL HERNIA REPAIR WITH A COMPOSIX KUGEL MESH. THE MEDICAL RECORDS REPORT THAT A CT SCAN ON (B)(4) 2007 SHOWED ANOTHER RECURRENCE, AND THAT THE PT ELECTED NOT TO HAVE IT REPAIRED UNTIL TWO YEARS LATER. ON (B)(4) 2009, IT WAS REPORTED THAT THE PT UNDERWENT EXCISION OF COMPOSIX KUGEL MESH AND REPAIR OF THE RECURRENCE NOTED IN THE (B)(4) 2007 CT SCAN, WITH A NON-BARD MESH. BASED ON THE INFO PROVIDED, IT IS UNK WHETHER THE DEVICE MAY HAVE CAUSED OR CONTRIBUTED TO THE REPORTED EVENT. THE PT HAS A NUMBER OF COMORBIDITIES AND A HISTORY OF RECURRENCE. THE MEDICAL RECORDS INDICATE THAT THE PT WAS TREATED FOR RECURRENCE AND ADHESIONS, BOTH OF WHICH ARE KNOWN POSSIBLE ADVERSE REACTIONS LISTED IN THE IFU. ADDITIONALLY, NO SAMPLE WAS RETURNED FOR EVAL. NO CONCLUSION CAN BE DRAWN AT THIS TIME. THE COMPOSIX KUGEL MESH IMPLANTED ON (B)(6) 2004 WAS REPORTED TO THE FDA IN ACCORDANCE WITH (B)(4).

    Description of Event or Problem · 1

    BASED ON MEDICAL RECORDS PROVIDED BY THE PT'S ATTORNEY: (B)(6) 2002 - PT UNDERWENT REPAIR OF INCISIONAL HERNIA WITH BARD FLAT MESH AND EXCISION OF OMENTAL NODULE. ON (B)(6) 2004 - PT UNDERWENT LYSIS OF ADHESIONS, EXCISION OF BARD FLAT MESH, AND REPAIR OF RECURRENT INCISIONAL HERNIA WITH COMPOSIX KUGEL MESH. ON (B)(6) 2004 - OFFICE NOTES, THE INCISION IS HEALING WELL, THERE IS NO EVIDENCE OF DRAINAGE OR INFECTION. THERE IS MINIMAL PALPABLE TENDERNESS. ON (B)(6) 2009 - PT UNDERWENT EXCISION OF COMPOSIX KUGEL MESH AND REPAIR OF RECURRENT INCISIONAL HERNIA WITH A NON-BARD MESH.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BARD FLAT MESH FTL DAVOL INC., SUB. C.R. BARD, INC. NA 43JLD236

    Patients

    Seq Age Sex Outcome Treatment
    1 38 YR Required Intervention