MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 08 report with the FDA on 2015-05-01 for MAXSTAR UNIT MOUNT LIGHT TL1000 manufactured by Marus.
[15900456]
A dental professional was performing routine medical treatment to a patient when the lens heat shield/holder fell off the marus dental light and hit the patient on the neck causing a slight burn. There were no serious injuries reported.
Patient Sequence No: 1, Text Type: D, B5
[16366503]
The lens heat shield/holder from the dental light has a three prong locking mechanism which locks the lens heat shield/holder into place. The lens heat shield/holder 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. The dental light is over 14 years old and is past the expected life of the device.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1017522-2015-00005 |
| MDR Report Key | 4745094 |
| Report Source | 08 |
| Date Received | 2015-05-01 |
| Date of Report | 2015-04-01 |
| Date of Event | 2015-02-07 |
| Date Mfgr Received | 2015-04-01 |
| Device Manufacturer Date | 2000-01-01 |
| Date Added to Maude | 2015-06-10 |
| 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 | MAXSTAR UNIT MOUNT LIGHT |
| Generic Name | DENTAL OPERATING LIGHT |
| Product Code | EAZ |
| Date Received | 2015-05-01 |
| 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 | 2015-05-01 |