MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional,user faci report with the FDA on 2017-08-08 for LUXSTAR TRACK-MOUNT DENTAL LIGHT TL1000 manufactured by Marus.
[82106979]
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.
Patient Sequence No: 1, Text Type: N, H10
[82106980]
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.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1017522-2017-00046 |
| MDR Report Key | 6774856 |
| Report Source | HEALTH PROFESSIONAL,USER FACI |
| Date Received | 2017-08-08 |
| Date of Report | 2017-07-20 |
| Date of Event | 2017-06-23 |
| Date Mfgr Received | 2017-07-20 |
| Device Manufacturer Date | 2010-10-22 |
| Date Added to Maude | 2017-08-08 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Reporter Occupation | DENTIST |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | MR. FRANK RAY |
| Manufacturer Street | 11727 FRUEHAUF DRIVE |
| Manufacturer City | CHARLOTTE NC 28273 |
| Manufacturer Country | US |
| Manufacturer Postal | 28273 |
| Manufacturer Phone | 7045877227 |
| Manufacturer G1 | MARUS |
| Manufacturer Street | 11727 FRUEHAUF DRIVE |
| Manufacturer City | CHARLOTTE NC 28273 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 28273 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | LUXSTAR TRACK-MOUNT DENTAL LIGHT |
| Generic Name | DENTAL LIGHT |
| Product Code | EAZ |
| Date Received | 2017-08-08 |
| Model Number | TL1000 |
| Catalog Number | TL1000 |
| Operator | DENTIST |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | MARUS |
| Manufacturer Address | 11727 FRUEHAUF DRIVE CHARLOTTE NC 28273 US 28273 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2017-08-08 |