BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SOLYX SIS SYSTEM

    MDR report key: 3032947 · Received April 3, 2013

    Report

    Report Number
    3005099803-2013-01976
    Event Type
    Injury
    Date Received
    April 3, 2013
    Report Date
    March 8, 2013
    Manufacturer
    BOSTON SCIENTIFIC - MARLBOROUGH
    Product Code
    FTL
    PMA / PMN Number
    K081275
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    NOTE: THIS MFR REPORT PERTAINS TO THE SECOND OF TWO DEVICES USED DURING THE SAME PROCEDURE. REFER TO ASSOCIATED MFR REPORT# 3005099803-2013-01975 FOR A DESCRIPTION OF THE OTHER DEVICE. IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A SOLYX SINGLE INCISION SLING SYSTEM WAS IMPLANTED ON (B)(6) 2011. ACCORDING TO THE COMPLAINANT, POST-PROCEDURE, THE PATIENT PRESENTED WITH UNSPECIFIED COMPLICATIONS. ACCORDING TO THE PHYSICIAN, NO COMPLICATIONS OCCURRED DURING THE PROCEDURE. THE PATIENT WAS ONLY SEEN ONCE POST-PROCEDURE (DATE UNKNOWN), AND NO COMPLAINTS WERE REPORTED. THE EXAMINATION WAS NORMAL. THE PATIENT CALLED IN A COMPLAINT OF SOME VAGINAL SPOTTING AT SOME POINT LATER (DATE UNKNOWN), AND WAS PRESCRIBED ESTROGEN CREAM. NO ADDITIONAL FOLLOW UP OR CONTACT HAS BEEN RECEIVED FROM THE PATIENT. ALL OTHER INFORMATION IS UNKNOWN AND UNAVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    137256 SOLYX SIS SYSTEM MESH, SURGICAL, POLYMERIC FTL BOSTON SCIENTIFIC - MARLBOROUGH UNK660

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention UPHOLD VAGINAL SUPPORT SYSTEM