BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LYNX SYSTEM

    MDR report key: 2904578 · Received January 9, 2013

    Report

    Report Number
    3005099803-2013-00077
    Event Type
    Injury
    Date Received
    January 9, 2013
    Report Date
    December 17, 2012
    Manufacturer
    BOSTON SCIENTIFIC - MARLBOROUGH
    Product Code
    FTL
    PMA / PMN Number
    K020110
    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 LYNX SUPRAPUBIC SLING SYSTEM WAS IMPLANTED ON (B)(6) 2006. 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 PAIN. ALL OTHER INFORMATION IS UNKNOWN AND UNAVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    12126 LYNX SYSTEM MESH, SURGICAL, POLYMERIC FTL BOSTON SCIENTIFIC - MARLBOROUGH M0068503000 0ML5082402

    Patients

    Seq Age Sex Outcome Treatment
    1 Other