FDA.reportPublic FDA data

MAUDE MDR 5904768

MDR report key
5904768
Report number
1017522-2016-00021
Event key
0
Event type
3
Date of event
2014-07-31
Date received
2016-08-25
Adverse event
3
Product problem
3
Patients in event
0
Reporter occupation
600
Health professional
3
Initial report to FDA
3
Event location
3

Manufacturer Contact#

Contact
MR. FRANK RAY
Address
11727 FRUEHAUF DRIVE CHARLOTTE NC 28273 US
Phone
704-704-7045
Report source
M
Manufacturer link flag
Y

Devices#

Seq, Brand, Generic table
SeqBrandGenericManufacturerProduct codeModelCatalogLotPMA510(k)ImplantEvaluatedAvailability
1LUXSTAR ORBIT MOUNT LIGHTDENTAL OPERATING LIGHTMARUSEAZOL1000OL1000R N

Patients#

Sequence, Received, Treatment table
SequenceReceivedTreatmentOutcome
12016-08-250

Event Narratives#

N

Patient 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. MARUS INITIATED A RECALL ON (B)(6) 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 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. MARUS RECEIVED THE INITIAL COMPLAINT NOTIFICATION FROM AN ATTORNEY WITH LIMITED AND VAGUE INFORMATION. MARUS WAS ABLE TO IDENTIFY THE END USER VIA AN INTERNET SEARCH AND SUCCESSFULLY CONTACTED THEM ON 8/25/16. MARUS CONFIRMED THE INCIDENT AND WAS ABLE TO OBTAIN ADDITIONAL INFORMATION ABOUT THIS EVENT. MARUS IS SHIPPING A TETHER KIT AT NO CHARGE TO THE DOCTOR FOR INSTALLATION.

D

Patient 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 CHEST CAUSING A RED BURN. THE DENTAL ASSISTANT APPLIED A WET PAPER TOWEL AND ICE TO THE RED BURN AREA.