BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OBTRYX SYSTEM

    MDR report key: 2853796 · Received December 3, 2012

    Report

    Report Number
    3005099803-2012-05793
    Event Type
    Injury
    Date Received
    December 3, 2012
    Report Date
    November 7, 2012
    Manufacturer
    BOSTON SCIENTIFIC - MARLBOROUGH
    Product Code
    FTL
    PMA / PMN Number
    K040787
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT THE PATIENT WAS IMPLANTED WITH AN OBTRYX CURVED TRANSOBTURATOR MID-URETHRAL SLING SYSTEM DURING A PROCEDURE ON (B)(6) 2006. ACCORDING TO THE COMPLAINANT, POST-PROCEDURE, THE PATIENT EXPERIENCED URINARY PROBLEMS, PELVIC AND ABDOMEN PAIN, DYSPAREUNIA, BLEEDING, URINARY TRACT INFECTION, STRESS URINARY INCONTINENCE, AND VAGINAL VAULT PROLAPSE (SPECIFICS UNKNOWN). ALL OTHER INFORMATION IS UNKNOWN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 OBTRYX SYSTEM MESH, SURGICAL, POLYMERIC FTL BOSTON SCIENTIFIC - MARLBOROUGH M0068504000 0ML5121203

    Patients

    Seq Age Sex Outcome Treatment
    1 Other