BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SOLYX SIS SYSTEM

    MDR report key: 2173113 · Received July 23, 2011

    Report

    Report Number
    3005099803-2011-02477
    Event Type
    Injury
    Date Received
    July 23, 2011
    Report Date
    June 24, 2011
    Manufacturer
    BOSTON SCIENTIFIC - MARLBOROUGH
    Product Code
    FTL
    PMA / PMN Number
    K081275
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UT, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    A REVIEW OF THE MANUFACTURING RECORDS FOR THIS LOT SHOWED NO EVIDENCE OF A MANUFACTURING RELATED POTENTIAL CAUSE FOR THIS EVENT.

    Description of Event or Problem · 1

    IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT THE PATIENT'S URTICARIA WAS RESOLVED AFTER BEING PRESCRIBED PREDNISONE (DATE AND DURATION UNKNOWN). THE PATIENT WAS ALSO PRESCRIBED ZYRTEC AND ALLEGRA ON (B)(6), 2011.

    Description of Event or Problem · 1

    IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A SOLYX SINGLE INCISION SLING SYSTEM WAS USED DURING A VAGINAL SLING PROCEDURE ON (B)(6) 2011. ACCORDING TO THE COMPLAINANT, THERE WERE NO COMPLICATIONS DURING THE INITIAL PROCEDURE. (B)(6) POST PROCEDURE (EXACT DATE UNKNOWN), THE PATIENT PRESENTED WITH HEADACHES, ITCHING FROM HEAD TO TOE, AND SWELLING OF THE FEET, LEGS, TOES AND HANDS. IT WAS REPORTED THAT THERE WAS NO VAGINAL SWELLING OR REDNESS, BUT THAT THE PATIENT APPEARED TO HAVE HIVES ON ALL EXTREMITIES. THE PATIENT WAS THEN GIVEN ALLERGY TESTS FOR POLYPROPYLENE MESH WITH POSITIVE RESULTS. THE PHYSICIAN PERFORMED A REMOVAL SURGERY ON (B)(6) 2011. THE PATIENT'S CURRENT CONDITION IS UNKNOWN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SOLYX SIS SYSTEM MESH, SURGICAL, POLYMERIC FTL BOSTON SCIENTIFIC - MARLBOROUGH M0068507001

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention