BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GORE DUALMESH PLUS BIOMATERIAL

    MDR report key: 1884410 · Received October 25, 2010

    Report

    Report Number
    2017233-2010-00474
    Event Type
    Injury
    Date Received
    October 25, 2010
    Date of Event
    January 1, 2007
    Report Date
    October 22, 2010
    Manufacturer
    W.L. GORE & ASSOCIATES
    Product Code
    FTL
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    METHOD - DEVICE NOT RETURNED FOR EVAL AND LOT# INFO IS UNK. LOT NUMBER INFO WAS NOT PROVIDED, THEREFORE, A REVIEW OF QUALITY RECORDS COULD NOT BE PERFORMED. THE DEVICE WAS NOT RETURNED, THEREFORE, A DIRECT PRODUCT ANALYSIS COULD NOT BE PERFORMED. BASED UPON THE AVAILABLE INFO, THE EXACT CAUSE FOR THE REPORTED EVENT CANNOT BE DETERMINED. ALL AVAILABLE INFO HAS BEEN PLACED ON FILE FOR TRACKING, TRENDING AND F/U. A SUPPLEMENTAL REPORT WILL BE SUBMITTED IF NEW INFO IS OBTAINED.

    Description of Event or Problem · 1

    IT WAS REPORTED TO GORE THAT A PT UNDERWENT A LOW ANTERIOR RESECTION AND PELVIC FLOOR RECONSTRUCTION IN (B)(6) 2004, WHERE GORE DUALMESH PLUS BIOMATERIAL WAS USED. IN 2005, THE PT REPORTED DIARRHEA AND PERINEAL PAIN. IN 2007, IT WAS REPORTED THAT THE PT UNDERWENT A COLONOSCOPY WITHOUT ANY COMPLICATIONS, HOWEVER, LATER THAT SAME YEAR, THE DEVICE WAS REPORTED TO HAVE BEEN EXPELLED THROUGH THE RECTUM.

    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 WLG106

    Patients

    Seq Age Sex Outcome Treatment
    1 Other