BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LYNX SYSTEM

    MDR report key: 2771924 · Received October 4, 2012

    Report

    Report Number
    3005099803-2012-04475
    Event Type
    Injury
    Date Received
    October 4, 2012
    Report Date
    September 10, 2012
    Manufacturer
    BOSTON SCIENTIFIC - MARLBOROUGH
    Product Code
    FTL
    PMA / PMN Number
    K020110
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    PHYSICIAN

    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) 2010. ACCORDING TO THE COMPLAINANT, POST-PROCEDURE, THE PATIENT EXPERIENCED STRESS URINARY INCONTINENCE, DYSPAREUNIA, ABDOMINAL AND PELVIC PAIN. ACCORDING TO THE PHYSICIAN'S OFFICE, AS OF THE LAST FOLLOW UP MEDICAL APPOINTMENT IN (B)(6) 2010 (EXACT DATE UNKNOWN), NO PATIENT COMPLICATIONS WERE REPORTED. ALL OTHER INFORMATION IS UNKNOWN AND UNAVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LYNX SYSTEM MESH, SURGICAL, POLYMERIC FTL BOSTON SCIENTIFIC - MARLBOROUGH M0068503001 1ML0052603

    Patients

    Seq Age Sex Outcome Treatment
    1 Other