BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SOLYX SIS SYSTEM

    MDR report key: 2180631 · Received July 27, 2011

    Report

    Report Number
    3005099803-2011-02518
    Event Type
    Injury
    Date Received
    July 27, 2011
    Report Date
    July 1, 2011
    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

    IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A SOLYX SINGLE INCISION SLING SYSTEM WAS USED DURING A SLING PLACEMENT PROCEDURE ON (B)(6), 2009. ACCORDING TO THE COMPLAINANT, POST PROCEDURE, THE PATIENT EXPERIENCED URINARY RETENTION REQUIRING SELF-CATHETERIZATION AND HAD MULTIPLE SURGICAL RECONSTRUCTIVE SURGERIES. THE DATE OF ONSET OF THE RETENTION AND THE DETAILS OF THE RECONSTRUCTIVE SURGERIES ARE UNKNOWN. THE PATIENT'S CURRENT CONDITION IS UNKNOWN. ATTEMPTS TO OBTAIN ADDITIONAL INFORMATION HAVE BEEN UNSUCCESSFUL TO DATE. SHOULD ADDITIONAL DETAILS BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    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 Required Intervention TOTAL VAGINAL HYSTERECTOMY.