BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OBTRYX HALO SYSTEM

    MDR report key: 1556307 · Received December 7, 2009

    Report

    Report Number
    3005099803-2009-05771
    Event Type
    Injury
    Date Received
    December 7, 2009
    Report Date
    November 9, 2009
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    FTL
    PMA / PMN Number
    K040787
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED TO BOSTON SCIENTIFIC CORP THAT AN OBTRYX HALO SYSTEM WAS USED DURING A SLING PLACEMENT PROCEDURE. ACCORDING TO THE COMPLAINANT, AFTER THE PROCEDURE, THE PT PRESENTED WITH LEG PAIN "RADIATING DOWN THE LEFT LEG". SEVERAL ATTEMPTS AT FOLLOW UP HAVE BEEN UNSUCCESSFUL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 OBTRYX HALO SYSTEM FTL BOSTON SCIENTIFIC CORPORATION M0068505000

    Patients

    Seq Age Sex Outcome Treatment
    1 Other