BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SOLYX SIS SYSTEM

    MDR report key: 2870690 · Received December 12, 2012

    Report

    Report Number
    3005099803-2012-06037
    Event Type
    Injury
    Date Received
    December 12, 2012
    Report Date
    November 28, 2012
    Manufacturer
    BOSTON SCIENTIFIC - MARLBOROUGH
    Product Code
    FTL
    PMA / PMN Number
    K081275
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WY, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    EXACT PATIENT AGE/DATE OF BIRTH IS UNKNOWN; HOWEVER THE PATIENT WAS REPORTED TO BE OVER 18 YEARS OLD.

    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) 2009. ACCORDING TO THE COMPLAINANT, POST-PROCEDURE, THE PATIENT PRESENTED WITH UNSPECIFIED COMPLICATIONS. ACCORDING TO THE PHYSICIAN'S OFFICE, AS OF A FOLLOW UP MEDICAL APPOINTMENT ON (B)(6)2009, NO PATIENT COMPLICATIONS WERE REPORTED. ALL OTHER INFORMATION IS UNKNOWN AND UNAVAILABLE.

    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) 2009. ACCORDING TO THE COMPLAINANT, POST-PROCEDURE, THE PATIENT PRESENTED WITH UNSPECIFIED COMPLICATIONS. ACCORDING TO THE PHYSICIAN'S OFFICE, AS OF A FOLLOW UP MEDICAL APPOINTMENT ON (B)(6) 2009, NO PATIENT COMPLICATIONS WERE REPORTED. ALL OTHER INFORMATION IS UNKNOWN AND UNAVAILABLE.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 Other