BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BARD FLAT MESH

    MDR report key: 2120435 · Received June 3, 2011

    Report

    Report Number
    1213643-2011-00257
    Event Type
    Injury
    Date Received
    June 3, 2011
    Date of Event
    March 10, 2006
    Report Date
    July 27, 2007
    Manufacturer
    DAVOL INC.
    Product Code
    FTL
    PMA / PMN Number
    PREAMENDMENT
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    INITIALLY THE ATTORNEY REPORTED THAT A SINGLE EVENT OF THE IMPLANT OF A COMPOSIX KUGEL MESH OCCURRED, HOWEVER, MEDICAL RECORDS WERE RECEIVED AND A REVIEW OF THESE RECORDS IDENTIFIED ANOTHER EVENT. BASED ON THE MEDICAL RECORD REVIEW, THE PT UNDERWENT REPAIR OF ABDOMINAL INCISIONAL HERNIA WITH BARD FLAT MESH ON (B)(6) 2005. AFTER SEVERAL AREAS OF ADHESIONS WERE LYSED, THE BARD FLAT MESH WAS TRIMMED TO SIZE AND PLACED OVERLAPPING THE HERNIA DEFECT. ON (B)(6) 2006, THE PT UNDERWENT REPAIR OF AN INCISIONAL HERNIA WITH A NON-BARD MESH. THE PREVIOUSLY PLACED BARD FLAT MESH WAS NOTED TO HAVE APPEARED TO BE FLOATING ON TOP OF THE SUBCUTANEOUS TISSUE AND THEREFORE WAS EXCISED IN ITS ENTIRETY. BASED ON THE INFO RECEIVED, IT IS UNK WHETHER THE DEVICE MAY HAVE CAUSED OR CONTRIBUTED TO THE EVENT. ADDITIONALLY, NO PRODUCT HAS BEEN RETURNED. NO CONCLUSION CAN BE DRAWN AT THIS TIME. INFO RELATED TO THE RECALLED COMPOSIX KUGEL MESH IMPLANTED ON (B)(6) 2004 HAS BEEN REPORTED IN ACCORDANCE WITH RAE (B)(4).

    Description of Event or Problem · 1

    BASED ON THE MEDICAL RECORDS PROVIDED BY THE PT'S ATTORNEY: ON (B)(6) 2004, PT UNDERWENT INCISIONAL HERNIA REPAIR WITH COMPOSIX KUGEL. ON (B)(6) 2004, PT ADMITTED FOR ABDOMINAL PAIN, POSSIBLE APPENDICITIS. PT UNDERWENT EXPLORATORY LAPAROTOMY, APPENDECTOMY, AND REMOVAL OF COMPOSIX KUGEL MESH. INFLAMMATION CLOSE TO THE MESH WAS NOTED, THE MESH WAS ADHERENT TO THE OMENTUM AND DISSECTED OUT. PT DISCHARGED ON (B)(6) 2004. ON (B)(6) 2005, PT UNDERWENT EXPLORATORY LAPAROTOMY AND REPAIR OF ABDOMINAL INCISIONAL HERNIA WITH BARD MESH. SEVERAL ADHESIONS WERE REMOVED. BARD FLAT MESH WAS TRIMMED TO SIZE AND PLACED OVERLAPPING THE DEFECT. ON (B)(6) 2006, PT UNDERWENT REPAIR OF INCISIONAL HERNIA WITH NON-BARD MESH. THE BARD FLAT MESH APPEARED TO BE FLOATING ON THE TOP OF THE SUBCUTANEOUS TISSUE AND WAS EXCISED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BARD FLAT MESH FTL DAVOL INC. NA 43APD035

    Patients

    Seq Age Sex Outcome Treatment
    1 51 YR Required Intervention