MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a distributor report with the FDA on 2018-06-07 for MARUS LUXSTAR UL1000 manufactured by Marus.
[110454797]
An authorized marus distributor service technician visually inspected the marus ul1000 dental light at the doctors office. It was identified that the tether was not attached to the lens heat shield cover. The tether will prevent the lens heat shield cover from falling off the light if it is not properly reinstalled after routine maintance. The lense heat shield cover has to be removed during routine maintenance when replacing the halogen light bulb or cleaning the lens covers. On (b)(6) 2018, the distributor service technician informed marus they installed the tether on the ul1000 dental light the prior week.
Patient Sequence No: 1, Text Type: N, H10
[110454798]
A dentist was positioning a marus dental light for use when the lense heat shield cover fell off the light and hit the patient on the lip causing a small contusion and laceration. There were no serious injuries reported.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1017522-2018-00018 |
| MDR Report Key | 7579523 |
| Report Source | DISTRIBUTOR |
| Date Received | 2018-06-07 |
| Date of Report | 2018-06-07 |
| Date of Event | 2018-05-23 |
| Date Mfgr Received | 2018-05-23 |
| Device Manufacturer Date | 2013-03-19 |
| Date Added to Maude | 2018-06-07 |
| 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 | MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE |
| 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 | KAVO DENTAL TECHNOLOGIES, LLC |
| 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 | MARUS LUXSTAR |
| Generic Name | DENTAL LIGHT |
| Product Code | EAZ |
| Date Received | 2018-06-07 |
| Model Number | UL1000 |
| Catalog Number | UL1000 |
| 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 | 2018-06-07 |