BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SOLYX SIS SYSTEM

    MDR report key: 3230433 · Received July 16, 2013

    Report

    Report Number
    3005099803-2013-05909
    Event Type
    Injury
    Date Received
    July 16, 2013
    Report Date
    June 18, 2013
    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

    Description of Event or Problem · 1

    NOTE: THIS REPORT PERTAINS TO ONE OF THREE DEVICES USED DURING THE SAME PROCEDURE. IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A UPHOLD VAGINAL SUPPORT SYSTEM (MFR REPORT #3005099803-2013-05766), PINNACLE POSTERIOR PELVIC FLOOR REPAIR KIT (MFR REPORT #3005099803-2013-05767) AND A SOLYX SINGLE INCISION SLING SYSTEM (MFR REPORT #3005099803-2013-05909) WERE IMPLANTED INTO THE PATIENT ON (B)(6) 2011. ACCORDING TO THE COMPLAINANT, THE PATIENT EXPERIENCED INJURIES (SPECIFICS UNKNOWN). ALL OTHER INFORMATION, INCLUDING THE PATIENT'S CURRENT CONDITION, IS UNKNOWN AND UNAVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    329887 SOLYX SIS SYSTEM MESH, SURGICAL, POLYMERIC FTL BOSTON SCIENTIFIC - MARLBOROUGH UNK660

    Patients

    Seq Age Sex Outcome Treatment
    1 Other