BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PREFYX PPS® SYSTEM

    MDR report key: 2914752 · Received January 14, 2013

    Report

    Report Number
    3005099803-2013-00206
    Event Type
    Injury
    Date Received
    January 14, 2013
    Report Date
    December 17, 2012
    Manufacturer
    BOSTON SCIENTIFIC - SPENCER
    Product Code
    FTL
    PMA / PMN Number
    K040787
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    ATTORNEY

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A PREFYX PREPUBIC SLING SYSTEM WAS IMPLANTED ON (B)(6), 2009.ACCORDING TO THE COMPLAINANT, POST-PROCEDURE, THE PATIENT EXPERIENCED VAGINAL EROSION, RECURRENT URINARY TRACT AND BLADDER INFECTIONS, MESH EROSION, BLADDER PERFORATIONS, INCONTINENCE, ABDOMINAL AND PELVIC AREA PAIN.ALL OTHER INFORMATION IS UNKNOWN AND UNAVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    21576 PREFYX PPS® SYSTEM MESH, SURGICAL, POLYMERIC FTL BOSTON SCIENTIFIC - SPENCER M0068506001 12599663

    Patients

    Seq Age Sex Outcome Treatment
    1 Other