BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MAXSTAR UNIT MOUNT LIGHT

    MDR report key: 2926477 · Received January 16, 2013

    Report

    Report Number
    1017522-2013-00002
    Event Type
    Malfunction
    Date Received
    January 16, 2013
    Date of Event
    December 20, 2012
    Report Date
    December 21, 2012
    Manufacturer
    MARUS
    Product Code
    EAZ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SC, 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. THE INSTALLATION INSTRUCTIONS, USE AND CARE INSTRUCTIONS, AND LABELING CLEARLY STATE TO ENSURE THE 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). MARUS NOTIFIED THE DISTRIBUTOR OF THE RECALL NUMEROUS TIMES WHILE THE RECALL WAS OPEN. THE DISTRIBUTOR RESPONDED BACK TO MARUS 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, THE DISTRIBUTOR WENT TO THE DENTAL OFFICE AND INSTALLED THE TETHER KIT ON (B)(6) 2013.

    Description of Event or Problem · 1

    A DOCTOR WAS PERFORMING ROUTINE MEDICAL TREATMENT TO A PATIENT WHEN THE LENS HEAT SHIELD/HOLDER FROM HIS DENTAL LIGHT CAME OFF THE LIGHT AND FELL ONTO THE PATIENTS CHEST THEN ROLLED UP TO THEIR NECK. THE DENTIST GAVE THE PATIENT SOME OVER THE COUNTER NEOSPORIN TO PUT ON THEIR NECK WHERE THE LENS HEAT SHIELD/HOLDER TOUCHED. THERE WERE NO SERIOUS INJURIES REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    23712 MAXSTAR UNIT MOUNT LIGHT DENTAL OPERATING LIGHT EAZ MARUS ML1000

    Patients

    Seq Age Sex Outcome Treatment
    1 57 YR