BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OBTRYX SYSTEM

    MDR report key: 3030721 · Received April 2, 2013

    Report

    Report Number
    3005099803-2013-01970
    Event Type
    Injury
    Date Received
    April 2, 2013
    Report Date
    March 8, 2013
    Manufacturer
    BOSTON SCIENTIFIC - MARLBOROUGH
    Product Code
    FTL
    PMA / PMN Number
    K040787
    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 AN OBTRYX TRANSOBTURATOR MID-URETHRAL SLING SYSTEM WAS IMPLANTED ON (B)(6) 2007. ACCORDING TO THE COMPLAINANT, POST-PROCEDURE, THE PATIENT PRESENTED WITH UNSPECIFIED COMPLICATIONS. ACCORDING TO THE PHYSICIAN, NO COMPLICATIONS WERE REPORTED WITH THE PROCEDURE. THE PATIENT WAS SEEN SEVERAL TIMES POST-PROCEDURE, WITH THE MOST RECENT APPOINTMENT ON (B)(6) 2007. NO PATIENT COMPLAINTS WERE REPORTED AND THE EXAMINATIONS WERE NORMAL. THE PATIENT HAS NOT SINCE BEEN SEEN. ALL OTHER INFORMATION IS UNKNOWN AND UNAVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    134750 OBTRYX SYSTEM MESH, SURGICAL, POLYMERIC FTL BOSTON SCIENTIFIC - MARLBOROUGH UNK676

    Patients

    Seq Age Sex Outcome Treatment
    1 Other