MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2016-02-08 for MAXIMA RU1200 manufactured by Henry Schein.
[38108935]
Patient was having a composite filing done of tooth #3 when she began to experience a burning sensation inside and outside the mouth while the staff was using the curing light.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5060114 |
| MDR Report Key | 5431165 |
| Date Received | 2016-02-08 |
| Date of Report | 2016-02-08 |
| Date of Event | 2016-02-02 |
| Date Added to Maude | 2016-02-11 |
| Event Key | 0 |
| Report Source Code | Voluntary report |
| Manufacturer Link | N |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Reporter Occupation | OTHER HEALTH CARE PROFESSIONAL |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | MAXIMA RU1200 |
| Generic Name | CURING LIGHT |
| Product Code | EBZ |
| Date Received | 2016-02-08 |
| Model Number | RU1200 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | * |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | HENRY SCHEIN |
| Manufacturer Address | MELVILLE NY US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2016-02-08 |