BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PROLIFT PELVIC FLOOR REPAIR

    MDR report key: 1023210 · Received March 25, 2008

    Report

    Report Number
    1023210
    Event Type
    Injury
    Date Received
    March 25, 2008
    Report Date
    February 27, 2008
    Manufacturer
    ETHICON, INC.
    Product Code
    FTL
    Adverse Event
    Yes
    Report Source
    User Facility report
    Reporter Location
    PA, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PT UNDERWENT AN ANTERIOR PELVIC FLOOR REPAIR PROCEDURE IN 2007. THE PT DEVELOPED AN AREA OF EXPOSED MESH IN THE VAGINAL APEX WITH VAGINAL DISCHARGE AND BLEEDING. THE PT RETURNED TO THE OPERATING ROOM FIVE MONTHS LATER, FOR EXCISION OF THE ERODED VAGINAL MESH.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PROLIFT PELVIC FLOOR REPAIR MESH, SURGICAL, POLYMERIC FTL ETHICON, INC. NA 2969129

    Patients

    Seq Age Sex Outcome Treatment
    1 72 YR Required Intervention