BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SOLYX SIS SYSTEM

    MDR report key: 1911834 · Received December 1, 2010

    Report

    Report Number
    3005099803-2010-04943
    Event Type
    Injury
    Date Received
    December 1, 2010
    Date of Event
    November 9, 2010
    Report Date
    November 9, 2010
    Manufacturer
    BOSTON SCIENTIFIC - MARLBOROUGH
    Product Code
    FTL
    PMA / PMN Number
    K081275
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WV, 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 SLING PROCEDURE. THE PATIENT WEIGHT WAS REPORTED TO BE (B)(6) POUNDS. ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE, THE FIRST SIDE WAS NOT INSERTED DEEP ENOUGH INTO THE TISSUE, BUT THE CARRIER WAS STILL DEPLOYED. WHEN THE PHYSICIAN ATTEMPTED TO PLACE THE SECOND SIDE, THE MESH COULD NOT BE SUFFICIENTLY TENSIONED. THE PATIENT LOST APPROXIMATELY 400CC OF BLOOD FROM THE RIGHT AND LEFT SIDE DISSECTIONS. IT WAS REPORTED THAT THE BLEEDING WAS CONTROLLED WITH PRESSURE. THE PROCEDURE WAS COMPLETED WITH A DIFFERENT DEVICE.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 37 YR Other