BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OBTRYX SYSTEM

    MDR report key: 3080386 · Received April 26, 2013

    Report

    Report Number
    3005099803-2013-02907
    Event Type
    Injury
    Date Received
    April 26, 2013
    Report Date
    April 2, 2013
    Manufacturer
    BOSTON SCIENTIFIC - MARLBOROUGH
    Product Code
    FTL
    PMA / PMN Number
    K040787
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, 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) 2008. ACCORDING TO THE COMPLAINANT, THE PATIENT EXPERIENCED AN UNKNOWN INJURY. ACCORDING TO THE PHYSICIAN, THE PROCEDURE WAS COMPLETED WITHOUT COMPLICATIONS. THE PATIENT RETURNED TO THE PHYSICIAN'S OFFICE IN (B)(6) 2011 COMPLAINING OF DYSPAREUNIA. THE PATIENT WAS TREATED WITH ESTROGEN. THE PATIENT RETURNED ON AN UNKNOWN DATE LATER REPORTING SYMPTOMS OF URINARY URGENCY AND URINARY FREQUENCY. THE PATIENT ALSO REPORTED ABDOMINAL PAIN WHICH WAS IDENTIFIED TO BE CAUSED BY AN ENLARGED LYMPH NODE. THE PATIENT ALSO HAD POLYCYSTIC KIDNEY DISEASE AND WAS SENT TO A UROLOGIST FOR ADDITIONAL FOLLOW-UP. THE PATIENT RETURNED IN (B)(6) 2012 REPORTING SUPRAPUBIC PAIN. THE PHYSICIAN ORDERED A CAT SCAN AND DETERMINED THE PAIN WAS LIKELY RELATED TO THE INTERSTITIAL CYSTITIS. THE PHYSICIAN PRESCRIBED UNKNOWN THERAPY FOR THE INTERSTITIAL CYSTITIS. THE PATIENT HAS NOT BEEN SEEN SINCE. 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
    182655 OBTRYX SYSTEM MESH, SURGICAL, POLYMERIC FTL BOSTON SCIENTIFIC - MARLBOROUGH UNK676

    Patients

    Seq Age Sex Outcome Treatment
    1 Other