BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LUXSTAR CEILING MOUNT LIGHT

    MDR report key: 3870124 · Received April 29, 2014

    Report

    Report Number
    1017522-2014-00006
    Event Type
    Malfunction
    Date Received
    April 29, 2014
    Date of Event
    April 7, 2014
    Report Date
    April 7, 2014
    Manufacturer
    MARUS
    Product Code
    EAZ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UT, US
    Reporter Occupation
    DENTIST

    Narratives

    Additional Manufacturer Narrative · 1

    THE LENS HEAT SHIELD/HOLDER FROM THE DENTAL LIGHT HAS A THREE PRONG LOCKING MECHANISM WHICH LOCKS THE LENS HEAT SHIELD/COVER INTO PLACE. THE LENS HEAT SHIELD/COVER HAS TO BE REMOVED BY THE END USER WHEN CLEANING THE LENS OR REPLACING THE HALOGEN BULB DURING ROUTINE OPERATOR MAINTENANCE. DENTAL EQUIPMENT LLC (DBA MARUS) INITIATED A RECALL ON JUNE 10, 2011 TO ADD A TETHER TO THE LENS HEAT SHIELD/COVER TO KEEP IT FROM FALLING OFF THE DENTAL LIGHT IF IT IS NOT RE-INSTALLED PROPERLY. THE FDA CLOSED THIS RECALL ON 10/26/2012 (PLEASE REFERENCE FDA RECALL Z-2834-2011). (B)(4) NOTIFIED THE DISTRIBUTOR OF THE RECALL WHILE THE RECALL WAS OPEN. THE DISTRIBUTOR RESPONDED BACK TO (B)(4) AND ACKNOWLEDGED THE RECALL BUT APPARENTLY THE DISTRIBUTOR DID NOT INSTALL THE TETHER KIT AT THIS ONE PARTICULAR DENTAL PRACTICE. AFTER FOLLOWING BACK UP WITH THE DENTIST ON (B)(6) 2014, THE DENTIST INFORMED (B)(4) THE TETHER WAS INSTALLED ON THE DENTAL LIGHT THE PRIOR WEEK.

    Description of Event or Problem · 1

    A DENTAL PROFESSIONAL WAS PERFORMING ROUTINE MEDICAL TREATMENT TO A PATIENT WHEN THE LENS HEAT SHIELD/HOLDER FELL OFF THE DENTAL LIGHT AND ONTO THE PATIENT'S NECK CAUSING A SMALL RED MARK. NO MEDICAL ATTENTION WAS REQUIRED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    256433 LUXSTAR CEILING MOUNT LIGHT DENTAL OPERATING LIGHT EAZ MARUS CL1000

    Patients

    Seq Age Sex Outcome Treatment
    1 44 YR