BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BRW LOCALIZER FRAME

    MDR report key: 1978755 · Received January 4, 2011

    Report

    Report Number
    1222895-2010-00026
    Event Type
    Malfunction
    Date Received
    January 4, 2011
    Report Date
    January 4, 2011
    Manufacturer
    INTEGRA RADIONICS, INC.
    Product Code
    HAW
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    TO DATE, THE DEVICE INVOLVED IN THE REPORTED INCIDENT HAS NOT BEEN RECEIVED FOR EVAL. AN INVESTIGATION HAS BEEN INITIATED BASED UPON THE REPORTED INFO.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT WHEN THE HEAD RING DRIVES (HRD) WERE FULLY RETRACTED, ONE OF THEM COLLIDED WITH THE BRW LOCALIZER FRAME. THERE WAS PT CONTACT. HOWEVER, THE PT WAS NOT TREATED. NO PT INJURY WAS REPORTED. ADDITIONAL CLINICAL INFO HAS BEEN REQUESTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BRW LOCALIZER FRAME NA HAW INTEGRA RADIONICS, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1