BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MLX 300W XENON LIGHT SOURCE

    MDR report key: 3871289 · Received April 15, 2014

    Report

    Report Number
    1222895-2014-00007
    Event Type
    Malfunction
    Date Received
    April 15, 2014
    Date of Event
    March 24, 2014
    Report Date
    March 31, 2014
    Manufacturer
    INTEGRA BURLINGTON, MA, INC.
    Product Code
    FCW
    PMA / PMN Number
    K081477
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FI
    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 ON THE REPORTED INFO.

    Description of Event or Problem · 1

    DEALER REPORTS THAT AFTER FIVE MINUTES OF STARTING DEVICE, SMELLS LIKE BURNING. ON (B)(6) 2014 DEALER REPORTS NO HARM DONE. OPERATING ROOM WAS SETTING UP FOR A VENTRICULAR SEPTAL DEFECT REPAIR. ISSUE OCCURRED BEFORE PROCEDURE, ON PRETEST.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    230643 MLX 300W XENON LIGHT SOURCE NA FCW INTEGRA BURLINGTON, MA, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 5 YR