BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OBTRYX SYSTEM

    MDR report key: 3163226 · Received June 11, 2013

    Report

    Report Number
    3005099803-2013-04392
    Event Type
    Injury
    Date Received
    June 11, 2013
    Report Date
    May 17, 2013
    Manufacturer
    BOSTON SCIENTIFIC - MARLBOROUGH
    Product Code
    OTN
    PMA / PMN Number
    K040787
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    ATTORNEY

    Narratives

    Additional Manufacturer Narrative · 1

    A SECOND ATTORNEY WAS REPORTED WITH THIS EVENT; CONTACT INFORMATION IS AS FOLLOWS: (B)(6).

    Description of Event or Problem · 1

    IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN OBTRYX TRANSOBTURATOR MID-URETHRAL SLING SYSTEM WAS IMPLANTED (B)(6) 2006. 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

    ADDITIONAL INFORMATION RECEIVED FROM THE COMPLAINANT ON JULY 28, 2014 NOTED THAT THE PATIENT EXPERIENCED SERIOUS BODILY INJURIES INCLUDING PAIN, DISCOMFORT, PRESSURE, DIFFICULTY VOIDING URINE, CONTINUED INCONTINENCE, DISCHARGE, SCARRING, INFECTION, ODOR AND BLEEDING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    263514 OBTRYX SYSTEM MESH, SURGICAL, POLYMERIC OTN BOSTON SCIENTIFIC - MARLBOROUGH UNK676

    Patients

    Seq Age Sex Outcome Treatment
    1 Other