BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LYNX SYSTEM

    MDR report key: 1895886 · Received November 10, 2010

    Report

    Report Number
    3005099803-2010-04632
    Event Type
    Injury
    Date Received
    November 10, 2010
    Report Date
    October 20, 2010
    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 AN LYNX SYSTEM WAS USED DURING A PROCEDURE PERFORMED ON (B)(6) 2006. ACCORDING TO THE COMPLAINANT, POST PROCEDURE, THE PATIENT PRESENTED WITH "SERIOUS BODILY INJURIES" INCLUDING "EROSION OF THE IMPLANTED MESH". A MESH REPAIR PROCEDURE WAS PERFORMED IN (B)(6) 2006.

    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