BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PREFYX PPS SYSTEM

    MDR report key: 2183199 · Received July 28, 2011

    Report

    Report Number
    3005099803-2011-02525
    Event Type
    Injury
    Date Received
    July 28, 2011
    Report Date
    July 5, 2011
    Manufacturer
    BOSTON SCIENTIFIC - MARLBOROUGH
    Product Code
    FTL
    PMA / PMN Number
    K040787
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A PREFYX PREPUBIC SLING SYSTEM WAS USED DURING A PROCEDURE ON (B)(6) 2007. ACCORDING TO THE COMPLAINANT, SINCE (B)(6) 2009, THE PATIENT BEGAN TO EXPERIENCE INCONTINENCE WHICH GOT PROGRESSIVELY WORSE. THE PATIENT ALSO EXPERIENCED DYSPAREUNIA AND GENERAL PAIN IN THE PELVIC REGION WHICH WORSENS WHEN URINATING. IT WAS REPORTED THAT THERE WERE NO COMPLICATIONS DURING THE INITIAL PROCEDURE. THE PATIENT WAS PRESCRIBED 8 MG OF TOVIAZ FOR AN UNDETERMINED AMOUNT OF TIME. THE PATIENT IS STILL TAKING TOVIAZ TO DATE. IT WAS REPORTED THAT THE PATIENT IS CURRENTLY STABLE, BUT STILL INCONTINENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PREFYX PPS SYSTEM MESH, SURGICAL, POLYMERIC FTL BOSTON SCIENTIFIC - MARLBOROUGH M0068506000 9493481

    Patients

    Seq Age Sex Outcome Treatment
    1 Other