MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2014-06-04 for ILLUMASK manufactured by La Lumiere, Llc.
[16015611]
After using the device i noticed my vision was blurred and i experienced distorted colors in my vision temporarily. Dates of use: (b)(6) 2014. Reason for use: anti-aging - reduce fine lines and wrinkles.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5036508 |
| MDR Report Key | 3866730 |
| Date Received | 2014-06-04 |
| Date of Report | 2014-06-03 |
| Date of Event | 2014-06-03 |
| Date Added to Maude | 2014-06-12 |
| 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 |
| Health Professional | 0 |
| 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 |
| Brand Name | ILLUMASK |
| Generic Name | ACNE LIGHT |
| Product Code | OLP |
| Date Received | 2014-06-04 |
| Lot Number | NP4048014017C1 |
| Device Availability | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | LA LUMIERE, LLC |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2014-06-04 |