MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2010-06-23 for 635 NANOMETER LIGHT (NHN) manufactured by Erchonia (erchmedic).
[1613623]
Patient had light therapy on face for trigeminal neuralgia. Treatment caused nausea, sweats, shaking, patient unable to drive and almost passing out. Patient has had four episodes since treatment. Now seeing neurologist and cardiologist for cause. Patient would like to know if goggles should have been worn during treatment.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5016476 |
| MDR Report Key | 1736530 |
| Date Received | 2010-06-23 |
| Date of Report | 2010-06-23 |
| Date of Event | 2010-04-28 |
| Date Added to Maude | 2010-06-29 |
| 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 | 0 |
| Reporter Occupation | PATIENT |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 0 |
| Event Location | 0 |
| Single Use | 0 |
| Previous Use Code | 0 |
| Event Type | 3 |
| Type of Report | 3 |
| Generic Name | 635 NANOMETER LIGHT (NHN) |
| Product Code | NHN |
| Date Received | 2010-06-23 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | ERCHONIA (ERCHMEDIC) |
| Manufacturer Address | 2021 COMMERCE DR. MCKINNEY TX 75069 US 75069 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2010-06-23 |