BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OBTRYX SYSTEM

    MDR report key: 3172550 · Received June 17, 2013

    Report

    Report Number
    3005099803-2013-05013
    Event Type
    Injury
    Date Received
    June 17, 2013
    Report Date
    May 24, 2013
    Manufacturer
    BOSTON SCIENTIFIC - MARLBOROUGH
    Product Code
    FTL
    PMA / PMN Number
    K040787
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, 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. ADDITIONAL INFORMATION RECEIVED FROM THE PHYSICIAN ON (B)(6) 2013 NOTED THAT THE PATIENT WAS IMPLANTED WITH AN ETHICON SPRAC DEVICE IN 2006 AND IT WAS FOUND TO HAVE ERODED A YEAR LATER. THE DEVICE WAS REMOVED ON THE SAME DAY THE OBTRYX WAS IMPLANTED; THERE WERE NO COMPLICATIONS ASSOCIATED WITH THE PROCEDURE. THE PATIENT WAS SEEN FOR A FOLLOW UP VISIT ON (B)(6) 2007 AND SHE WAS VERY PLEASED WITH THE DEVICE AND HAD NO COMPLAINTS. THE PATIENT HAS NOT BEEN SEEN OR HEARD FROM SINCE. 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
    273799 OBTRYX SYSTEM MESH, SURGICAL, POLYMERIC FTL BOSTON SCIENTIFIC - MARLBOROUGH UNK676

    Patients

    Seq Age Sex Outcome Treatment
    1 Other