BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OBTRYX SYSTEM

    MDR report key: 2992146 · Received March 7, 2013

    Report

    Report Number
    3005099803-2013-01490
    Event Type
    Injury
    Date Received
    March 7, 2013
    Report Date
    February 15, 2013
    Manufacturer
    BOSTON SCIENTIFIC - MARLBOROUGH
    Product Code
    FTL
    PMA / PMN Number
    K040787
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    NOTE: THIS MFR REPORT PERTAINS TO THE SECOND OF TWO DEVICES USED DURING THE SAME PROCEDURE. REFER TO ASSOCIATED MFR REPORT# 3005099803-2013-01437 FOR A DESCRIPTION OF THE OTHER DEVICE. IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT THE PATIENT WAS IMPLANTED WITH AN OBTRYX TRANSOBTURATOR MID-URETHRAL SLING SYSTEM DURING A PROCEDURE ON (B)(6) 2011. ACCORDING TO THE COMPLAINANT, POST-PROCEDURE, THE PATIENT EXPERIENCED COMPLICATIONS (SPECIFICS UNKNOWN). ACCORDING TO THE PHYSICIAN'S OFFICE, AS OF A FOLLOW UP APPOINTMENT ON (B)(6) 2011, NO COMPLICATIONS WERE REPORTED WITH THE PROCEDURE. THE PATIENT WAS DOING WELL WITH NO COMPLAINTS. AS OF THE MOST RECENT ANNUAL APPOINTMENT ON (B)(6) 2013, THE EXAMINATION WAS NORMAL WITH NO PATIENT COMPLAINTS REPORTED. ALL OTHER INFORMATION IS UNKNOWN AND UNAVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    98056 OBTRYX SYSTEM MESH, SURGICAL, POLYMERIC FTL BOSTON SCIENTIFIC - MARLBOROUGH UNK676

    Patients

    Seq Age Sex Outcome Treatment
    1 Other UPHOLD VAGINAL SUPPORT SYSTEM