BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LYNX SYSTEM

    MDR report key: 3130016 · Received May 24, 2013

    Report

    Report Number
    3005099803-2013-04478
    Event Type
    Injury
    Date Received
    May 24, 2013
    Report Date
    May 10, 2013
    Manufacturer
    BOSTON SCIENTIFIC - MARLBOROUGH
    Product Code
    FTL
    PMA / PMN Number
    K020110
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NE, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A LYNX SUPRAPUBIC MID-URETHRAL SLING SYSTEMWAS IMPLANTED ON (B)(6), 2011.ACCORDING TO THE COMPLAINANT, THE PATIENT EXPERIENCED AN UNKNOWN INJURY.ACCORDING TO THE PHYSICIAN'S OFFICE, THE PATIENT WAS LAST SEEN ON (B)(6), 2011 AND HAD PRESENTED WITH TWO INCIDENTS OF URINARY TRACT INFECTIONS AFTER THE PROCEDURE. THE PATIENT WAS PRESCRIBED MEDICATION FOR THE INFECTION. ALL OTHER INFORMATION IS UNKNOWN. SHOULD ADDITIONAL RELEVANT DETAILS BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    232170 LYNX SYSTEM MESH, SURGICAL, POLYMERIC FTL BOSTON SCIENTIFIC - MARLBOROUGH M0068503000 1ML0081902

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention