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 2018-11-16 for MARUS LUXSTAR UL1000 manufactured by Kavo Dental Technologies, Llc.
[128081957]
An authorized distributor service technician visually inspected the marus ul1000 dental light at the doctors office and determined the lense heat shield cover had not been properly re-attached to the marus ul1000 dental light during routine maintenance by the end user. The lense heat shield cover has to be removed during routine maintenance when replacing the halogen light bulb or cleaning the lens covers. The use and care manual identifies how to properly re-install the lense heat shield cover after performing routine maintenance as well as list warnings to insure the lense heat shield cover is properly installed after servicing. The distributor service technician informed the manufacturer they properly installed the lense heat shield cover on the ul 1000 dental light. This concludes the investigation.
Patient Sequence No: 1, Text Type: N, H10
[128081958]
It was reported a dentist was positioning a marus ul1000 dental light for use when the lense heat shield cover fell off the light and hit the patient on the forehead causing a bruise and swelling. The dentist gave the patient an ice pack for the swelling. There were no serious injuries reported.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1017522-2018-00030 |
| MDR Report Key | 8081206 |
| Report Source | HEALTH PROFESSIONAL,USER FACI |
| Date Received | 2018-11-16 |
| Date of Report | 2018-11-16 |
| Date of Event | 2018-10-31 |
| Date Mfgr Received | 2018-10-31 |
| Device Manufacturer Date | 1999-01-01 |
| Date Added to Maude | 2018-11-16 |
| 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 | 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 | 2018-11-16 |
| Model Number | UL1000 |
| Catalog Number | UL1000 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | KAVO DENTAL TECHNOLOGIES, LLC |
| Manufacturer Address | 11727 FRUEHAUF DRIVE CHARLOTTE NC 28273 US 28273 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2018-11-16 |