MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2016-08-25 for LUXSTAR ORBIT MOUNT LIGHT OL1000 manufactured by Marus.
[54040798]
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.
Patient Sequence No: 1, Text Type: N, H10
[54040799]
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.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1017522-2016-00021 |
| MDR Report Key | 5904768 |
| Date Received | 2016-08-25 |
| Date of Report | 2016-07-27 |
| Date of Event | 2014-07-31 |
| Date Mfgr Received | 2016-07-27 |
| Device Manufacturer Date | 2004-10-26 |
| Date Added to Maude | 2016-08-25 |
| 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 | ATTORNEY |
| 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 | 0 |
| Brand Name | LUXSTAR ORBIT MOUNT LIGHT |
| Generic Name | DENTAL OPERATING LIGHT |
| Product Code | EAZ |
| Date Received | 2016-08-25 |
| Model Number | OL1000 |
| Catalog Number | OL1000 |
| Operator | DENTAL ASSISTANT |
| 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 | 2016-08-25 |