BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ANCILLARY, XENON ULTRALITE SWE

    MDR report key: 3612940 · Received December 26, 2013

    Report

    Report Number
    1222895-2013-00036
    Event Type
    Malfunction
    Date Received
    December 26, 2013
    Report Date
    December 17, 2013
    Manufacturer
    INTEGRA BURLINGTON, MA, INC.
    Product Code
    FCW
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, 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 ON THE REPORTED INFORMATION.

    Description of Event or Problem · 1

    DOCTOR KEPT COMPLAINING THAT THE HEADLIGHT WAS TOO HOT SO WE ENDED UP REMOVING IT FROM HIS HEAD AND REPLACING IT WITH ANOTHER. WHEN WE TOOK A LOOK AT THE FOCAL POINT OF THE LAMP, WE REALIZED THAT THE HEAT WAS SO STRONG THAT IT BURNT THE METAL. (B)(6) 2013 CUSTOMER REPORTS DOCTOR WAS PERFORMING A CORONARY ARTERY BYPASS AND THE HEADLIGHT HAD BEEN IN USE FOR 2 HOURS. HEADLIGHT WAS USED WITH INTEGRA CABLE #0023009 PER CUSTOMER AND BFW-MAXENON XI-300 (PRODUCT #3010, SERIAL # (B)(4)). THERE WAS NO INJURY TO THE DOCTOR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    675874 ANCILLARY, XENON ULTRALITE SWE NA FCW INTEGRA BURLINGTON, MA, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1