BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OBTRYX SYSTEM

    MDR report key: 2950689 · Received February 8, 2013

    Report

    Report Number
    3005099803-2013-00736
    Event Type
    Injury
    Date Received
    February 8, 2013
    Report Date
    January 22, 2013
    Manufacturer
    BOSTON SCIENTIFIC - MARLBOROUGH
    Product Code
    OTN
    PMA / PMN Number
    K040787
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WV, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    AS REPORTED BY THE PATIENT¿S ATTORNEY, A BOSTON SCIENTIFIC DEVICE WAS IMPLANTED. 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

    IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN OBTRYX TRANSOBTURATOR MID-URETHRAL SLING SYSTEM WAS IMPLANTED ON (B)(6), 2008.ACCORDING TO THE COMPLAINANT, POST-PROCEDURE, THE PATIENT PRESENTED WITH UNSPECIFIED COMPLICATIONS.ALL OTHER INFORMATION IS UNKNOWN AND UNAVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    54174 OBTRYX SYSTEM MESH, SURGICAL, SYNTHETIC, UROGYNECOLOGIC, FOR STRESS URINARY INCONTINENCE, RETR OTN BOSTON SCIENTIFIC - MARLBOROUGH M0068505001 0ML8063002

    Patients

    Seq Age Sex Outcome Treatment
    1 Other