BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SOLYX SIS SYSTEM

    MDR report key: 2021525 · Received March 17, 2011

    Report

    Report Number
    3005099803-2011-00829
    Event Type
    Injury
    Date Received
    March 17, 2011
    Report Date
    February 24, 2011
    Manufacturer
    BOSTON SCIENTIFIC - MARLBOROUGH
    Product Code
    FTL
    PMA / PMN Number
    K081275
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WV, 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 CYSTOCELE REPAIR PROCEDURE. THIS IS THE SAME CASE AND PATIENT AS MFR REPORT # 3005099803-2011-00846. THIS REPORT PERTAINS TO THE SECOND OF TWO DEVICES. ACCORDING TO THE COMPLAINANT, THE PATIENT WAS IN RETENTION FOR TWO WEEKS. THE PATIENT WAS CATHETERIZED FOR THAT TIME UNTIL THE RETENTION RESOLVED ON ITS OWN. THE EXACT DATE OF THE PROCEDURE AND THE DATE THE PATIENT PRESENTED WITH RETENTION IS UNKNOWN AND REPORTEDLY UNAVAILABLE. THE PATIENT'S CURRENT CONDITION WAS REPORTED TO BE "FINE." ATTEMPTS TO OBTAIN ADDITIONAL INFORMATION REGARDING THIS EVENT HAVE BEEN UNSUCCESSFUL. SHOULD ADDITIONAL, RELEVANT 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 Other