BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SOLYX SIS SYSTEM

    MDR report key: 3071071 · Received April 22, 2013

    Report

    Report Number
    3005099803-2013-02863
    Event Type
    Injury
    Date Received
    April 22, 2013
    Report Date
    March 28, 2013
    Manufacturer
    BOSTON SCIENTIFIC - MARLBOROUGH
    Product Code
    FTL
    PMA / PMN Number
    K081275
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A SOLYX SIS SYSTEM WAS IMPLANTED IN 2005. ACCORDING TO THE COMPLAINANT, THE PATIENT STATES AS A RESULT OF THE IMPLANT SHE SUFFERED EROSION AND EXTRUSION OF THE MESH, CAUSING SEVERE PERSISTENT PAIN, NERVE DAMAGE, WEIGHT GAIN, AND AN INABILITY TO PERFORM HOUSEHOLD FUNCTIONS AND SEXUAL RELATIONS. ALL OTHER INFORMATION IS UNKNOWN. SHOULD ADDITIONAL RELEVANT DETAILS BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    171378 SOLYX SIS SYSTEM MESH, SURGICAL, POLYMERIC FTL BOSTON SCIENTIFIC - MARLBOROUGH UNK660

    Patients

    Seq Age Sex Outcome Treatment
    1 Other LYNX SUPRAPUBIC MID-URETHRAL SLING SYSTEM