BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SOLYX SIS SYSTEM

    MDR report key: 1902359 · Received November 18, 2010

    Report

    Report Number
    3005099803-2010-04716
    Event Type
    Malfunction
    Date Received
    November 18, 2010
    Date of Event
    October 28, 2010
    Report Date
    October 28, 2010
    Manufacturer
    BOSTON SCIENTIFIC - MARLBOROUGH
    Product Code
    FTL
    PMA / PMN Number
    K081275
    Product Problem
    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 A SOLYX SIS SYSTEM WAS USED DURING A MIDURETHRAL SLING PROCEDURE. THE PATIENT AGE WAS REPORTED TO BE OVER 18 YEARS. ACCORDING TO THE COMPLAINANT, DURING THE PLACEMENT OF THE FIRST SIDE OF THE DEVICE, THE MESH TORE NEAR THE MESH CARRIER BUT DID NOT DETACH FROM THE MESH CARRIER. IT WAS REPORTED THAT THE PHYSICIAN DID ENCOUNTER RESISTANCE DURING THE ADVANCEMENT OF THE DEVICE. 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 1ML0060903

    Patients

    Seq Age Sex Outcome Treatment
    1