BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LYNX SYSTEM

    MDR report key: 1973080 · Received January 28, 2011

    Report

    Report Number
    3005099803-2011-00175
    Event Type
    Injury
    Date Received
    January 28, 2011
    Report Date
    January 5, 2011
    Manufacturer
    BOSTON SCIENTIFIC - MARLBOROUGH
    Product Code
    FTL
    PMA / PMN Number
    K020110
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OK, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A PATIENT UNDERWENT A SURGICAL PROCEDURE ON (B)(6), 2006 INVOLVING A LYNX SUPRAPUBIC MID-URETHRAL SLING SYSTEM.ACCORDING TO THE COMPLAINANT, FOLLOWING THE PROCEDURE, THE PATIENT SUFFERED FROM CONTINUED STRESS URINARY INCONTINENCE, EROSION OF INTERNAL BODILY TISSUE AND DYSPAREUNIA. THE PATIENT'S CONDITION AT THE CONCLUSION OF THE PROCEDURE AND THE PATIENT'S CURRENT CONDITION ARE UNKNOWN AND REPORTEDLY UNAVAILABLE.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 Other