BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LUMINANT LOCALIZER

    MDR report key: 2062494 · Received March 18, 2011

    Report

    Report Number
    1222895-2011-00004
    Event Type
    Malfunction
    Date Received
    March 18, 2011
    Report Date
    March 18, 2011
    Manufacturer
    INTEGRA, BURLINGTON
    Product Code
    HAW
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    A LUMINANT LOCALIZER LL01, WAS INVOLVED IN AN EVENT THAT WAS DESCRIBED AS FOLLOWS: THE LOCALIZER BOX CRACKED DURING THE USE OF THE CRW AND THE LOCATION OF THE EAR BARS SOMETIMES PUTS THE FRAME TOO LOW FOR BIGGER HEADS. THE UNIT WAS IN CONTACT WITH THE PT, BUT IT IS UNK WHETHER THERE WAS ANY INJURY INVOLVED WITH THIS EVENT. ADDITIONAL CLINICAL INFORMATION HAS BEEN REQUESTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LUMINANT LOCALIZER N/A HAW INTEGRA, BURLINGTON

    Patients

    Seq Age Sex Outcome Treatment
    1