BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OBTRYX SYSTEM

    MDR report key: 3217552 · Received July 10, 2013

    Report

    Report Number
    3005099803-2013-06622
    Event Type
    Injury
    Date Received
    July 10, 2013
    Report Date
    June 13, 2013
    Manufacturer
    BOSTON SCIENTIFIC - MARLBOROUGH
    Product Code
    FTL
    PMA / PMN Number
    K040787
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    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) 2007. ACCORDING TO THE COMPLAINANT, THE PATIENT EXPERIENCED AN UNKNOWN INJURY. ACCORDING TO THE PHYSICIAN¿S OFFICE, IN (B)(6) 2007, TWO WEEKS POST-PROCEDURE, THE PATIENT HAD HER FIRST EXAMINATION. THE PATIENT DID NOT COMPLAIN OF PAIN OR INCONTINENCE. SHE REPORTED SOME DISCHARGE, BUT THERE WAS NO EROSION. THE PATIENT ALSO EXPERIENCED CONSTIPATION AND WAS TREATED WITH STOOL SOFTENERS. NO OTHER ABNORMALITIES WERE NOTED. LABORATORY TESTS (SPECIFICS UNKNOWN) WERE NORMAL. IN (B)(6) 2007, THE PATIENT RETURNED FOR A URINALYSIS AND ¿REVIEW OF ALL SYSTEMS¿ (SPECIFICS UNKNOWN) AND EVERYTHING WAS NORMAL. IN (B)(6) 2007, THE PATIENT EXPERIENCED A URINARY TRACT INFECTION, A YEAST INFECTION, AND DYSPAREUNIA. SHE WAS TREATED WITH ANTIBIOTICS AND VAGINAL CREAM (TYPE UNKNOWN) AND REPORTED FEELING BETTER FOLLOWING TREATMENT. IN BOTH (B)(6) 2008, THE PATIENT DID NOT RETURN FOR SCHEDULED CHECK-UPS. IN (B)(6) 2008, THE PATIENT COMPLAINED OF A RECURRENT URINARY TRACT INFECTION, URINARY FREQUENCY, URINARY URGENCY, AND DISCOMFORT. SHE WAS GIVEN THE SAME TREATMENT OF ANTIBIOTICS AND VAGINAL CREAM (TYPE UNKNOWN). 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
    318794 OBTRYX SYSTEM MESH, SURGICAL, POLYMERIC FTL BOSTON SCIENTIFIC - MARLBOROUGH UNK676

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention