BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SOLYX SIS SYSTEM

    MDR report key: 2833421 · Received November 15, 2012

    Report

    Report Number
    3005099803-2012-05353
    Event Type
    Injury
    Date Received
    November 15, 2012
    Report Date
    October 23, 2012
    Manufacturer
    BOSTON SCIENTIFIC - MARLBOROUGH
    Product Code
    FTL
    PMA / PMN Number
    K081275
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(6).

    Additional Manufacturer Narrative · 1

    (B)(6).

    Description of Event or Problem · 1

    IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A SOLYX SINGLE INCISION SLING SYSTEM WAS IMPLANTED ON AN UNKNOWN DATE. THE ADVANTAGE FIT SYSTEM AND THE UPHOLD VAGINAL SUPPORT SYSTEM WERE ALSO IMPLANTED. THE IMPLANTATION DATES PROVIDED ARE (B)(6) 2010, BUT IT WAS NOT SPECIFIED WHICH DEVICE/S WERE IMPLANTED ON EACH DATE. ACCORDING TO THE COMPLAINANT, POST-PROCEDURE, THE PATIENT PRESENTED WITH UNSPECIFIED COMPLICATIONS. ALL OTHER INFORMATION IS UNKNOWN.

    Description of Event or Problem · 1

    IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A SOLYX SINGLE INCISION SLING SYSTEM WAS IMPLANTED ON AN UNKNOWN DATE. AN UPHOLD VAGINAL SUPPORT SYSTEM WAS ALSO IMPLANTED. THE IMPLANTATION DATES PROVIDED ARE (B)(6) 2010 AND (B)(6) 2010, BUT IT WAS NOT SPECIFIED WHICH DEVICE/S WERE IMPLANTED ON EACH DATE. THE ADVANTAGE FIT SYSTEM WAS IMPLANTED ON (B)(6) 2010. ALL OTHER INFORMATION IS UNKNOWN.

    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