BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OBTRYX SYSTEM

    MDR report key: 2973089 · Received February 21, 2013

    Report

    Report Number
    3005099803-2013-00771
    Event Type
    Injury
    Date Received
    February 21, 2013
    Report Date
    January 29, 2013
    Manufacturer
    BOSTON SCIENTIFIC - MARLBOROUGH
    Product Code
    FTL
    PMA / PMN Number
    K040787
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).THE REPORTED LOT NUMBER, 8011113ML, COULD NOT BE VERIFIED. CONSEQUENTLY, THE MANUFACTURE AND EXPIRATION DATES CANNOT BE DETERMINED.

    Description of Event or Problem · 1

    IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT THE PATIENT WAS IMPLANTED WITH AN OBTRYX HALO TRANSOBTURATOR MID-URETHRAL SLING SYSTEM WITHOUT COMPLICATIONS ON AN UNKNOWN DATE. POST-PROCEDURE, THE PATIENT HAD APPROXIMATELY 200ML OF RESIDUAL URINE AND NEEDED TO SELF-CATHETERIZE IN ORDER TO EMPTY HER BLADDER. REPORTEDLY, FURTHER IMPROVEMENTS ARE NOT EXPECTED (SPECIFICS UNKNOWN).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    75502 OBTRYX SYSTEM MESH, SURGICAL, POLYMERIC FTL BOSTON SCIENTIFIC - MARLBOROUGH M0068505001

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention