BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SOLYX SIS SYSTEM

    MDR report key: 3181557 · Received June 21, 2013

    Report

    Report Number
    3005099803-2013-04999
    Event Type
    Injury
    Date Received
    June 21, 2013
    Report Date
    May 29, 2013
    Manufacturer
    BOSTON SCIENTIFIC - MARLBOROUGH
    Product Code
    FTL
    PMA / PMN Number
    K081275
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A SOLYX SINGLE INCISION SLING SYSTEM WAS IMPLANTED INTO THE PATIENT ON (B)(6) 2011. ACCORDING TO THE PHYSICIAN, THE DEVICE WAS IMPLANTED INTO THE PATIENT DURING A VAGINAL HYSTERECTOMY PROCEDURE WITH SOLYX SLING PLACEMENT FOR TOTAL PROLAPSE. THERE WERE NO COMPLICATIONS NOTED WITH THE PROCEDURE. IN (B)(6) 2012, THE PATIENT PRESENTED WITH COMPLAINTS OF DYSPAREUNIA. AN EXAM REVEALED THAT ONE END OF THE SLING HAD ERODED THROUGH. A SMALL PIECE WAS EXCISED. A FOLLOW-UP VISIT ON (B)(6) 2012, REVEALED THAT THE PATIENT WAS HEALING WELL WITH NO FURTHER COMPLAINTS, PAIN OR DISCOMFORT. THE PATIENT WAS VOIDING WELL, AND THE SLING WAS HOLDING UP WELL. THE PATIENT WAS SCHEDULED FOR ANOTHER VISIT ON (B)(6) 2013, BUT DID NOT SHOW UP FOR THE APPOINTMENT. ALL OTHER INFORMATION, INCLUDING THE PATIENT'S CURRENT CONDITION, IS UNKNOWN AND UNAVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    281891 SOLYX SIS SYSTEM MESH, SURGICAL, POLYMERIC FTL BOSTON SCIENTIFIC - MARLBOROUGH UNK660

    Patients

    Seq Age Sex Outcome Treatment
    1 46 YR Required Intervention