BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LUXSTAR CEILING MOUNT LIGHT

    MDR report key: 3297742 · Received August 14, 2013

    Report

    Report Number
    1017522-2013-00013
    Event Type
    Injury
    Date Received
    August 14, 2013
    Date of Event
    July 17, 2013
    Report Date
    July 18, 2013
    Manufacturer
    MARUS
    Product Code
    EAZ
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    NOT APPLICABLE

    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. THE INSTALLATION INSTRUCTIONS, USE AND CARE INSTRUCTIONS, AND LABELING CLEARLY STATE TO ENSURE TO LENS HEAT SHIELD/HOLDER IS PROPERLY SECURE BY SNAPPING THE PART BACK INTO PLACE. DENTAL EQUIPMENT LLC (B)(4) 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). WHEN NOTIFIED THE DISTRIBUTOR OF THE RECALL NUMEROUS TIMES 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 DISTRIBUTOR ON 08/05/2013, THE DISTRIBUTOR INFORMED (B)(4) THE TETHER WAS INSTALLED ON THE DENTAL LIGHT ON JULY 29, 2013.

    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 PATIENTS ARM CAUSING A BURN. THE BURN BLISTERED UP SO THE PATIENT WAS TAKEN FOR MEDICAL TREATMENT. SEVERAL ATTEMPTS WERE MADE TO DETERMINE THE TYPES OF MEDICAL TREATMENT PROVIDED TO THE PATIENT HOWEVER (B)(4) WAS UNABLE TO OBTAIN THIS INFORMATION FROM THE DENTIST OFFICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    392642 LUXSTAR CEILING MOUNT LIGHT DENTAL OPERATING LIGHT EAZ MARUS CL1000

    Patients

    Seq Age Sex Outcome Treatment
    1 5 YR Other