MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a consumer,other report with the FDA on 2017-03-07 for IN LIGHT WELLNESS SYSTEMS LED LIGHT THERAPY DEVICE manufactured by In Light Wellness Systems.
[69322929]
In light wellness systems has contacted the clinic and patient for additional information. The clinic has not yet returned the device for investigation. At this time, the patient is unwilling to respond to any questions. The dhr was reviewed and shows that the device was manufactured to the current standards and did not present any non-conformances through building and testing.
Patient Sequence No: 1, Text Type: N, H10
[69322930]
Patient reported that exposure to "in light wellness system" aggravated a pre-existing herpesviral keratitis eye infection that was virtually in remission. Infection was re-ignited, with significant inflammation and damage to his cornea, despite use of zirgen at the time. Patient alleged there were no warnings or questions regarding eye infections. Light was directed to his eyes.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3010709091-2017-00001 |
| MDR Report Key | 6385633 |
| Report Source | CONSUMER,OTHER |
| Date Received | 2017-03-07 |
| Date of Report | 2017-02-07 |
| Date of Event | 2016-12-30 |
| Date Mfgr Received | 2017-02-07 |
| Device Manufacturer Date | 2016-04-20 |
| Date Added to Maude | 2017-03-07 |
| 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 | 0 |
| Initial Report to FDA | 0 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | EMILY MELONE |
| Manufacturer Street | 5601 MIDWAY PARK PLACE NE |
| Manufacturer City | ALBUQUERQUE NM 87109 |
| Manufacturer Country | US |
| Manufacturer Postal | 87109 |
| Manufacturer Phone | 5054047130 |
| Manufacturer G1 | IN LIGHT WELLNESS SYSTEMS |
| Manufacturer Street | 5601 MIDWAY PARK PI NE |
| Manufacturer City | ALBUQUERQUE NM 87109 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 87109 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | IN LIGHT WELLNESS SYSTEMS LED LIGHT THERAPY DEVICE |
| Generic Name | LAMP, INFRARED, THERAPEUTIC HEATING |
| Product Code | ILY |
| Date Received | 2017-03-07 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | IN LIGHT WELLNESS SYSTEMS |
| Manufacturer Address | 5601 MIDWAY PARK PI NE ALBUQUERQUE NM 87109 US 87109 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Deathisabilit | 2017-03-07 |