BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GORE DUALMESH PLUS BIOMATERIAL

    MDR report key: 2893962 · Received December 21, 2012

    Report

    Report Number
    3003910212-2012-00037
    Event Type
    Injury
    Date Received
    December 21, 2012
    Date of Event
    January 24, 2012
    Report Date
    November 25, 2012
    Manufacturer
    W.L. GORE & ASSOCIATES
    Product Code
    FTL
    PMA / PMN Number
    K063435
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED TO GORE THAT ON (B)(6) 2010, A PT UNDERWENT MULTIPLE, CONSECUTIVE PROCEDURES, INCLUDING AN ABDOMINAL HYSTERECTOMY, AN ANTERIOR COLPOSUSPENSION (BURCH TYPE) AND SACRAL COLPOPEXY PROCEDURE FOR THE TREATMENT OF MENORRHAGIA, ADEMONYSIS, CYSTOCELE, RECTOCELE, URINARY STRESS INCONTINENCE AND VAGINAL PROLAPSE. GORE DUALMESH PLUS BIOMATERIAL WAS REPORTED TO BE USED IN THE SACRAL COLPOPEXY PROCEDURE. THE PT ALLEGES TO HAVE SUFFERED INJURIES INCLUDING BUT NOT LIMITED TO PAIN AND BLEEDING DUE TO ALLEGED MESH DEVICE EROSION AND HAS UNDERGONE TWO SUBSEQUENT PROCEDURE (ON (B)(6) 2011 AND (B)(6) 2012) WHEREBY THE DEVICE WAS REMOVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 GORE DUALMESH PLUS BIOMATERIAL FTL/MESH, SURGICAL, POLYMERIC FTL W.L. GORE & ASSOCIATES 06809362

    Patients

    Seq Age Sex Outcome Treatment
    1 48 YR Required Intervention