BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LYNX SYSTEM

    MDR report key: 2853380 · Received November 30, 2012

    Report

    Report Number
    3005099803-2012-05792
    Event Type
    Injury
    Date Received
    November 30, 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
    CA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT THE PATIENT WAS IMPLANTED WITH A LYNX SUPRAPUBIC SLING SYSTEM DURING A PROCEDURE ON (B)(6) 2007. ACCORDING TO THE COMPLAINANT, POST-PROCEDURE, THE PATIENT EXPERIENCED COMPLICATIONS (SPECIFICS UNKNOWN). ALL OTHER INFORMATION IS UNKNOWN.

    Description of Event or Problem · 1

    ACCORDING TO THE PHYSICIAN, POST PROCEDURE IN (B)(6) 2009, THE PATIENT COMPLAINED OF A BURNING FEELING DURING URINATION. AN UNKNOWN MEDICATION WAS PRESCRIBED FOR THE ISSUE. THE PATIENT WAS LAST SEEN IN (B)(6) 2010 AND REPORTEDLY ALL WOUNDS WERE HEALED AND SHE HAD MINIMAL PAIN. 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 UNK564

    Patients

    Seq Age Sex Outcome Treatment
    1 Other