BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SOLYX SIS SYSTEM

    MDR report key: 3914171 · Received July 3, 2014

    Report

    Report Number
    3005099803-2014-02302
    Event Type
    Injury
    Date Received
    July 3, 2014
    Date of Event
    May 29, 2014
    Report Date
    June 4, 2014
    Manufacturer
    BOSTON SCIENTIFIC - MARLBOROUGH
    Product Code
    PAH
    PMA / PMN Number
    K081275
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE COMPLAINANT INDICATED THAT THE DEVICE WAS IMPLANTED AND WILL NOT BE RETURNED FOR EVALUATION; THEREFORE, A FAILURE ANALYSIS OF THE COMPLAINT DEVICE COULD NOT BE COMPLETED. IF ANY FURTHER RELEVANT INFORMATION IS IDENTIFIED, A SUPPLEMENTAL MEDWATCH WILL BE FILED.

    Description of Event or Problem · 1

    IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A SOLYX¿ SIS SYSTEM WAS USED DURING A CONCOMITANT NATIVE TISSUE POSTERIOR PROLAPSE REPAIR PROCEDURE PERFORMED ON (B)(6), 2014. ACCORDING TO THE COMPLAINANT, ON (B)(6), 2014, THE SUBJECT EXPERIENCED DIFFICULTY EMPTYING HER BLADDER. THE EVENT RESOLVED ON (B)(6), 2014.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    391907 SOLYX SIS SYSTEM MESH, SURGICAL, SYNTHETIC PAH BOSTON SCIENTIFIC - MARLBOROUGH M0068507001 ML00002042

    Patients

    Seq Age Sex Outcome Treatment
    1 55 YR Required Intervention