BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SOLYX SIS SYSTEM

    MDR report key: 2981667 · Received February 27, 2013

    Report

    Report Number
    3005099803-2013-01083
    Event Type
    Injury
    Date Received
    February 27, 2013
    Report Date
    February 13, 2013
    Manufacturer
    BOSTON SCIENTIFIC - MARLBOROUGH
    Product Code
    FTL
    PMA / PMN Number
    K081275
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    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 IMPLANTED ON (B)(6), 2011.ACCORDING TO THE COMPLAINANT, POST-PROCEDURE, THE PATIENT EXPERIENCED EROSION AND EXTRUSION OF THE MESH. AS A RESULT, THE PATIENT EXPERIENCED SEVERE PERSISTENT PAIN, NERVE DAMAGE, WEIGHT GAIN, AND LOSS OF SEXUAL FUNCTION.ACCORDING TO THE PHYSICIAN'S OFFICE, AS OF A FOLLOW UP MEDICAL APPOINTMENT (DATE UNKNOWN), THE PATIENT SEEMED FINE. HOWEVER, THE PATIENT WAS REFERRED TO A UROLOGIST.ALL OTHER INFORMATION IS UNKNOWN AND UNAVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    83438 SOLYX SIS SYSTEM MESH, SURGICAL, POLYMERIC FTL BOSTON SCIENTIFIC - MARLBOROUGH M0068507000 1ML0092006

    Patients

    Seq Age Sex Outcome Treatment
    1 Other