BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OBTRYX SYSTEM

    MDR report key: 3140495 · Received May 31, 2013

    Report

    Report Number
    3005099803-2013-03785
    Event Type
    Injury
    Date Received
    May 31, 2013
    Date of Event
    August 17, 2011
    Report Date
    June 30, 2021
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    OTN
    PMA / PMN Number
    K040787
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    003

    Narratives

    Description of Event or Problem · 1

    AS REPORTED BY THE PATIENT'S ATTORNEY, AN OBTRYX TRANSOBTURATOR MID-URETHRAL SLING SYSTEM (MFR REPORT #3005099803-2013-03785) AND AN UPHOLD VAGINAL SUPPORT SYSTEM (MFR REPORT #3005099803-2013-04473) WERE IMPLANTED INTO THE PATIENT ON (B)(6) 2011. ACCORDING TO THE COMPLAINANT, THE PATIENT EXPERIENCED AN UNKNOWN INJURY. ALL OTHER INFORMATION IS UNKNOWN. SHOULD ADDITIONAL RELEVANT DETAILS BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN OBTRYX TRANSOBTURATOR MID-URETHRAL SLING SYSTEM WAS IMPLANTED ON AN UNKNOWN DATE. ACCORDING TO THE COMPLAINANT, THE PATIENT EXPERIENCED AN UNKNOWN INJURY. 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
    241369 OBTRYX SYSTEM MESH, SURGICAL, SYNTHETIC, UROGYNECOLOGIC, FOR STRESS URINARY INCONTINENCE, RETR OTN BOSTON SCIENTIFIC CORPORATION UNK676

    Patients

    Seq Age Sex Outcome Treatment
    1 Other