BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OBTRYX SYSTEM

    MDR report key: 3173759 · Received June 17, 2013

    Report

    Report Number
    3005099803-2013-05046
    Event Type
    Injury
    Date Received
    June 17, 2013
    Report Date
    May 23, 2013
    Manufacturer
    BOSTON SCIENTIFIC - MARLBOROUGH
    Product Code
    FTL
    PMA / PMN Number
    K040787
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN OBTRYX HALO SINGLE SYSTEM DEVICE WAS IMPLANTED ON (B)(6) 2013. ACCORDING TO THE COMPLAINANT, 24 HOURS POST-PROCEDURE, THE PATIENT EXPERIENCED LEG PAIN. THE PATIENT, USING A WALKER, WAS SEEN BY THE PHYSICIAN ON (B)(6) 2013 FOR SEVERE LEG PAIN. REPORTEDLY, THE PATIENT IS BEING TREATED FOR HER PAIN WITH AN UNKNOWN NARCOTIC. 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
    273870 OBTRYX SYSTEM MESH, SURGICAL, POLYMERIC FTL BOSTON SCIENTIFIC - MARLBOROUGH M0068505000

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention