BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SOLYX SIS SYSTEM

    MDR report key: 3253980 · Received July 30, 2013

    Report

    Report Number
    3005099803-2013-07085
    Event Type
    Injury
    Date Received
    July 30, 2013
    Report Date
    July 2, 2013
    Manufacturer
    BOSTON SCIENTIFIC - MARLBOROUGH
    Product Code
    FTL
    PMA / PMN Number
    K081275
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    THIS REPORT PERTAINS TO ONE OF TWO DEVICES USED DURING THE SAME PROCEDURE. ASSOCIATED MANUFACTURER REPORT # 3005099803-2013-08302 PERTAINS TO THE OTHER DEVICE.IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A SOLYX SIS SYSTEM WAS IMPLANTED (B)(6), 2010.ACCORDING TO THE COMPLAINANT, THE PATIENT EXPERIENCED VAGINAL BLEEDING, NERVE DAMAGE, VAGINAL SCARRING, PAINFUL URINATION, NOCTURIA, RECURRENT URINARY TRACT INFECTIONS, VAGINAL PAIN, ABDOMINAL PAIN AND PELVIC PAIN AS A RESULT OF THE IMPLANT.ALL OTHER INFORMATION IS UNKNOWN. SHOULD ADDITIONAL RELEVANT DETAILS BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    355570 SOLYX SIS SYSTEM MESH, SURGICAL, POLYMERIC FTL BOSTON SCIENTIFIC - MARLBOROUGH M0068507001 0ML9081001

    Patients

    Seq Age Sex Outcome Treatment
    1 Other UPHOLD VAGINAL SUPPORT SYSTEM