BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OBTRYX II SYSTEM

    MDR report key: 3678258 · Received March 13, 2014

    Report

    Report Number
    3005099803-2014-01394
    Event Type
    Injury
    Date Received
    March 13, 2014
    Date of Event
    February 2, 2014
    Report Date
    February 20, 2014
    Manufacturer
    BOSTON SCIENTIFIC - MARLBOROUGH
    Product Code
    OTN
    PMA / PMN Number
    K121754
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN OBTRYX II SYSTEM WAS IMPLANTED INTO THE PATIENT ON (B)(6) 2013, AND THE PATIENT WAS DISCHARGED THE FOLLOWING DAY, (B)(6) 2103. ON (B)(6) 2014, AT HER 6-MONTH FOLLOW-UP VISIT, THE PATIENT REPORTED A URINARY TRACT INFECTION WITH AN ONSET DATE OF (B)(6) 2014. THIS WAS TREATED WITH "AZO AND CIPRO", AND THE URINARY TRACT INFECTION WAS RESOLVED AS OF (B)(6) 2014.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    151163 OBTRYX II SYSTEM MESH, SURGICAL, SYNTHETIC OTN BOSTON SCIENTIFIC - MARLBOROUGH M0068504110 ML00001436

    Patients

    Seq Age Sex Outcome Treatment
    1 47 YR Required Intervention