BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OBTRYX SYSTEM

    MDR report key: 3050434 · Received April 10, 2013

    Report

    Report Number
    3005099803-2013-02157
    Event Type
    Injury
    Date Received
    April 10, 2013
    Report Date
    March 15, 2013
    Manufacturer
    BOSTON SCIENTIFIC - MARLBOROUGH
    Product Code
    FTL
    PMA / PMN Number
    K040787
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    ATTORNEY

    Narratives

    Additional Manufacturer Narrative · 1

    THE COMPLAINANT LISTED TWO FACILITIES ASSOCIATED WITH THIS COMPLAINT, SALINE MEMORIAL HOSPITAL, (B)(6). IT IS UNKNOWN WHICH FACILITY THE DEVICE WAS IMPLANTED AT. THE COMPLAINANT ALSO LISTED THE FOLLOWING PHYSICIANS ASSOCIATED WITH THIS COMPLAINT: (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 ON AN UNKNOWN DATE. THE IMPLANTATION DATES PROVIDED ARE (B)(6) 2009, (B)(6) 2010. HOWEVER, IT WAS NOT SPECIFIED ON WHICH DATE THE DEVICE WAS IMPLANTED. ACCORDING TO THE COMPLAINANT, POST-PROCEDURE, THE PATIENT EXPERIENCED PAIN DUE TO THE ERODED MESH, ADDITIONAL MEDICAL TREATMENT AND PROCEDURES. ALL OTHER INFORMATION IS UNKNOWN AND UNAVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    153244 OBTRYX SYSTEM MESH, SURGICAL, POLYMERIC FTL BOSTON SCIENTIFIC - MARLBOROUGH UNK676

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention