MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2017-01-30 for IN LIGHT WELLNESS SYSTEM manufactured by In Light Wellness Systems.
[66383554]
Exposure to "in light wellness system" aggravated a pre-existing herpesviral keratitis (800. 52) eye infection that was virtually in remission. Infection was re-ignited, with significant inflammation and damage to my cornea, despite use of zirgen at the time. There were no warnings or questions regarding eye infections, light was directed to eyes. (b)(6) was the practitioner who utilized the light therapy.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5067595 |
| MDR Report Key | 6294201 |
| Date Received | 2017-01-30 |
| Date of Report | 2017-01-30 |
| Date of Event | 2016-12-30 |
| Date Added to Maude | 2017-02-01 |
| 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 | PATIENT |
| 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 | IN LIGHT WELLNESS SYSTEM |
| Generic Name | THERAPEUTIC HEATING LAMP |
| Product Code | ILY |
| Date Received | 2017-01-30 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | IN LIGHT WELLNESS SYSTEMS |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Deathisabilit | 2017-01-30 |