BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SOLYX SIS SYSTEM

    MDR report key: 1932261 · Received December 17, 2010

    Report

    Report Number
    3005099803-2010-05153
    Event Type
    Injury
    Date Received
    December 17, 2010
    Date of Event
    November 19, 2010
    Report Date
    November 24, 2010
    Manufacturer
    BOSTON SCIENTIFIC - MARLBOROUGH
    Product Code
    FTL
    PMA / PMN Number
    K081275
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE INITIAL REPORTED EVENT WAS A SERIOUS INJURY, FOLLOW UP CONFIRMED THERE TO BE NO SERIOUS INJURY; THEREFORE, THE EVENT IS NO LONGER ASSESSED AS AN MDR REPORTABLE EVENT.

    Description of Event or Problem · 1

    IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A SOLYX SIS SYSTEM WAS USED DURING A SLING PROCEDURE. ACCORDING TO THE COMPLAINANT, AFTER THE PROCEDURE, THE PATIENT FELT PELVIC PAIN ON HER LEFT SIDE. THE DOCTOR WILL DO A CT SCAN TO CHECK FOR HEMATOMA. SEVERAL ATTEMPTS AT FOLLOW UP HAVE BEEN UNSUCCESSFUL.

    Description of Event or Problem · 1

    ACCORDING TO THE COMPLAINANT, THE PATIENT IS NO LONGER IN PAIN AND THE PAIN HAS "RELIEVED BY ITSELF." NO HEMATOMA WAS FOUND BUT THE PATIENT WAS REPORTED TO BE EXPERIENCING LEAKAGE. THE PATIENT'S CURRENT CONDITION 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

    Patients

    Seq Age Sex Outcome Treatment
    1 Other