BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OBTRYX SYSTEM

    MDR report key: 1831756 · Received September 13, 2010

    Report

    Report Number
    3005099803-2010-03803
    Event Type
    Injury
    Date Received
    September 13, 2010
    Report Date
    August 16, 2010
    Manufacturer
    BOSTON SCIENTIFIC - MARLBOROUGH
    Product Code
    FTL
    PMA / PMN Number
    K040787
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WV, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN OBTRYX HALO SYSTEM WAS USED DURING AN UNKNOWN PROCEDURE. ACCORDING TO THE COMPLAINANT, THE PATIENT PRESENTED WITH POST OPERATIVE LEG PAIN. THE PATIENT'S CURRENT CONDITION WAS REPORTED TO BE "FINE". IT IS UNKNOWN IF MEDICAL INTERVENTION WAS REQUIRED. NO ADDITIONAL INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 OBTRYX SYSTEM MESH, SURGICAL, POLYMERIC FTL BOSTON SCIENTIFIC - MARLBOROUGH M0068505000

    Patients

    Seq Age Sex Outcome Treatment
    1 Other