BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SOLYX SIS SYSTEM

    MDR report key: 1934116 · Received December 21, 2010

    Report

    Report Number
    3005099803-2010-05220
    Event Type
    Malfunction
    Date Received
    December 21, 2010
    Date of Event
    November 30, 2010
    Report Date
    November 30, 2010
    Manufacturer
    BOSTON SCIENTIFIC - MARLBOROUGH
    Product Code
    FTL
    PMA / PMN Number
    K081275
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A SOLYX SIS SYSTEM WAS USED DURING A MID URETHRAL SLING PROCEDURE. ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE, THE PHYSICIAN PLACED THE FIRST MESH CARRIER INTO THE PATIENT'S RIGHT SIDE. WHEN SHE WAS ABOUT TO PLACE THE SECOND MESH CARRIER, SHE NOTICED THAT "THE SECOND SIDE WAS TORN." THE PHYSICIAN REMOVED THE FIRST MESH CARRIER. THE PROCEDURE WAS COMPLETED WITH ANOTHER SOLYX SIS SYSTEM. THERE WERE NO PATIENT COMPLICATIONS AND THE PATIENT'S CONDITION AT THE CONCLUSION OF THE PROCEDURE WAS REPORTED TO BE "FINE."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SOLYX SIS SYSTEM MESH, SURGICAL, POLYMERIC FTL BOSTON SCIENTIFIC - MARLBOROUGH M0068507000 1ML0071501

    Patients

    Seq Age Sex Outcome Treatment
    1 52 YR