MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 08 report with the FDA on 2015-02-04 for LUZSTAR TRACK-MOUNT LIGHT TL1000 manufactured by Marus.
[5568094]
It was reported that a dentist was using a marus dental light during a routine dental procedure when the dental light fell down towards the ground hitting the pt on the right ear lobe causing a small contusion. There were no serious injuries reported.
Patient Sequence No: 1, Text Type: D, B5
[12913342]
Upon evaluation by the marus distributor it was identified that the pivot rotational stop screw had broken off due to a suspected excessive external force. This in turn caused damage to the brass pivot retainer which lead to the flex arm pivot to drop out of the suspension tube causing the light to fall down towards the ground.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1017522-2015-00002 |
| MDR Report Key | 4490703 |
| Report Source | 08 |
| Date Received | 2015-02-04 |
| Date of Report | 2015-01-08 |
| Date of Event | 2015-01-08 |
| Date Mfgr Received | 2015-01-08 |
| Device Manufacturer Date | 2009-08-01 |
| Date Added to Maude | 2015-03-12 |
| 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 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 0 |
| Event Location | 0 |
| Manufacturer Contact | FRANK RAY |
| Manufacturer Street | 11727 FRUEHAUF DR. |
| Manufacturer City | CHARLOTTE NC 28273 |
| Manufacturer Country | US |
| Manufacturer Postal | 28273 |
| Manufacturer Phone | 7045877227 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | LUZSTAR TRACK-MOUNT LIGHT |
| Generic Name | DENTAL LIGHT |
| Product Code | EAZ |
| Date Received | 2015-02-04 |
| Model Number | TL1000 |
| Catalog Number | TL1000 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | MARUS |
| Manufacturer Address | 11727 FRUEHAUF DR. CHARLOTTE NC 28273 US 28273 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2015-02-04 |