MAUDE Adverse Event Report: MARUS LUXSTAR TRACK-MOUNT DENTAL LIGHT

Model Number TL1000

Device Problem Detachment Of Device Component (1104)

Patient Problem Burn(s) (1757)

Event Date 06/23/2017

Event Type  Injury  

Manufacturer Narrative

The lens heat shield cover 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 cover is properly secure by snapping the part back into place.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 recall z-2834-2011).Marus notified all distributors of the recall while the recall was open.The distributor responded back to marus and acknowledged the recall but apparently did not install the tether kit at this one particular dental practice.After following back up with the dentist on (b)(6) 2017, the dentist informed marus the tether was installed on the dental light and is working properly.

Event Description

A dentist was positioning the dental light for use when the lens heat shield cover fell off the dental light and onto the patients neck causing a burn.The dr.Applied over the counter burn cream to the affected area.The patient followed up with the dentist 3 weeks later and the dentist believes the burn may be turning into a scar.

• Brand Name: LUXSTAR TRACK-MOUNT DENTAL LIGHT
• Type of Device: DENTAL LIGHT
• Manufacturer (Section D): MARUS; 11727 fruehauf drive; charlotte NC 28273
• Manufacturer (Section G): MARUS; 11727 fruehauf drive; charlotte NC 28273
• Manufacturer Contact: frank ray ; 11727 fruehauf drive; charlotte, NC 28273 ; 7045877227
• MDR Report Key: 6774856
• MDR Text Key: 82106979
• Report Number: 1017522-2017-00046
• Device Sequence Number: 1
• Product Code: EAZ
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,user faci
• Reporter Occupation: Dentist
• Type of Report: Initial
• Report Date: 07/20/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/08/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Dentist
• Device Model Number: TL1000
• Device Catalogue Number: TL1000
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/20/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/22/2010
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Outcome(s): Other