BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LYNX SYSTEM

    MDR report key: 2863038 · Received December 10, 2012

    Report

    Report Number
    3005099803-2012-05884
    Event Type
    Injury
    Date Received
    December 10, 2012
    Report Date
    November 7, 2012
    Manufacturer
    BOSTON SCIENTIFIC - MARLBOROUGH
    Product Code
    FTL
    PMA / PMN Number
    K020110
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    RI, 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) 2005. ACCORDING TO THE COMPLAINANT, POST-PROCEDURE, THE PATIENT EXPERIENCED URINARY PROBLEMS, PELVIC PAIN, ABDOMINAL PAIN, DYSPAREUNIA, BLEEDING, URINARY TRACT INFECTION, STRESS URINARY INCONTINENCE, AND VAGINAL VAULT PROLAPSE. ALL OTHER INFORMATION IS UNKNOWN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LYNX SYSTEM MESH, SURGICAL, POLYMERIC FTL BOSTON SCIENTIFIC - MARLBOROUGH M0068503000 0ML5061504

    Patients

    Seq Age Sex Outcome Treatment
    1 Other