BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OBTRYX SYSTEM

    MDR report key: 3100319 · Received May 8, 2013

    Report

    Report Number
    3005099803-2013-03323
    Event Type
    Injury
    Date Received
    May 8, 2013
    Report Date
    April 23, 2013
    Manufacturer
    BOSTON SCIENTIFIC - MARLBOROUGH
    Product Code
    FTL
    PMA / PMN Number
    K040787
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WV, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    PATIENT ALSO HAD AN OBTRYX TRANSOBTURATOR MID-URETHRAL SLING SYSTEM IMPLANTED ON (B)(6) 2008. TWO IMPLANTING SURGEONS WERE REPORTED. IT IS NOT KNOWN WHICH SURGEON PERFORMED WHICH PROCEDURE. THE SECOND REPORTED SURGEON IS DR (B)(6).

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION RECEIVED FROM THE PHYSICIAN'S OFFICE ON (B)(6) 2013 STATED THAT THE PATIENT HAD NO COMPLICATIONS.

    Description of Event or Problem · 1

    IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN OBTRYX TRANSOBTURATOR MID-URETHRAL SLING SYSTEM WAS IMPLANTED ON (B)(6) 2006. ACCORDING TO THE COMPLAINANT, POST-PROCEDURE, THE PATIENT PRESENTED WITH AN UNSPECIFIED INJURY. 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
    200331 OBTRYX SYSTEM MESH, SURGICAL, POLYMERIC FTL BOSTON SCIENTIFIC - MARLBOROUGH M0068505000 0ML6090712

    Patients

    Seq Age Sex Outcome Treatment
    1 Other