BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CORDUROY DUAL MESH

    MDR report key: 468572 · Received June 24, 2003

    Report

    Report Number
    MW1028812
    Event Type
    Injury
    Date Received
    June 24, 2003
    Date of Event
    June 3, 2003
    Report Date
    June 16, 2003
    Manufacturer
    W.L. GORE AND ASSOCIATES
    Product Code
    FTL
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    IN, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    IN 2002 PT UNDERWENT TOTAL ABDOMINAL HYSTERECTOMY WITH BURCH ABDOMINAL SACRAL COLPOPEXY. ON 3 OCCASIONS IN 2003 PT UNDERWENT SURGERY FOR REPAIR OF VAGINAL CUFF.

    Description of Event or Problem · 1

    ADD'L INFO REC'D IN 08/21/2003: THE EVENT WAS DESCRIBED AS FOLLOWS: IN 2002 PT UNDERWENT TOTAL ABDOMINAL HYSTERECTOMY WITH BURCH ABDOMINAL SACRAL COLPOPEXY. IN 2003 PT UNDERWENT SURGERY FOR REPAIR OF VAGINAL CUFF. THIS DOES NOT TELL THE CO HOW THE PRODUCT WAS USED, WHERE IT WAS IMPLANTED, OR THE NATURE OF THE INTERVENTION. WITHOUT SUCH INFO, IT IS IMPOSSIBLE TO DETERMINE WHETHER THE EVENTS DESCRIBED IN THE MEDICAL DEVICE REPORT ARE OR ARE NOT ATTRIBUTABLE TO THE DEVICE. "REACTION" WAS LISTED AS AN EVENT PROBLEM ON THE REPORT. THE EPTFE PRODUCTS HAVE BEEN ON THE MARKET FOR OVER 25 YEARS, AND CO HAS NEVER BEEN ABLE TO CONFIRM A CASE OF ALLERGIC REACTION AND REJECTION. (CO IS AWARE OF THE POTENTIAL FOR REACTION TO THE CHLORHEXIDINE AND/OR SILVER, WHICH IS PRESENT ON PLUS PRODUCTS AND LABELED APPROPRIATELY IN IFU). THE CO'S UNDERSTANDING OF CO'S EPTFE IS THAT SUCH REACTIONS ARE NOT POSSIBLE. THE CO REGULARLY SEARCH THE LITERATURE AND HAVE NEVER FOUND ANY PUBLISHED ACCOUNT OF ALLERGIC REACTION OR REJECTION TO CO'S PRODUCT. "DEVICE FAILURE" WAS ALSO LISTED AS AN EVENT PROBLEM ON THE REPORT. THE CO REVIEWED THE MANUFACTURING PAPERWORK ASSOCIATED WITH THIS LOT AND VERIFIED THAT ALL QUALITY SPECIFICATIONS HAD BEEN MET. THE CO ALSO RESEARCHED THE COMPLAINT/COMMENT DATABASE, AND CO HAS NO RECORD OF ANY OTHER ENTRIES ASSOCIATED WITH THIS LOT NUMBER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CORDUROY DUAL MESH BIOMATERIAL FTL W.L. GORE AND ASSOCIATES 1DLMCO2 01289243

    Patients

    Seq Age Sex Outcome Treatment
    1 34 YR Required Intervention