MAUDE Adverse Event Report: IN LIGHT WELLNESS SYSTEMS IN LIGHT WELLNESS SYSTEMS LED LIGHT THERAPY DEVICE; LAMP, INFRARED, THERAPEUTIC HEATING

Device Problem Patient-Device Incompatibility (2682)

Patient Problem Keratitis (1944)

Event Date 12/30/2016

Event Type  Injury  

Manufacturer Narrative

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.

Event Description

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.

• Brand Name: IN LIGHT WELLNESS SYSTEMS LED LIGHT THERAPY DEVICE
• Type of Device: LAMP, INFRARED, THERAPEUTIC HEATING
• Manufacturer (Section D): IN LIGHT WELLNESS SYSTEMS; 5601 midway park pi ne; albuquerque NM 87109
• Manufacturer (Section G): IN LIGHT WELLNESS SYSTEMS; 5601 midway park pi ne; albuquerque NM 87109
• Manufacturer Contact: emily melone ; 5601 midway park place ne; albuquerque, NM 87109 ; 5054047130
• MDR Report Key: 6385633
• MDR Text Key: 69322929
• Report Number: 3010709091-2017-00001
• Device Sequence Number: 1
• Product Code: ILY
• Combination Product (y/n): N
• PMA/PMN Number: K101894
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer,other
• Type of Report: Initial
• Report Date: 02/07/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/07/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 02/07/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/20/2016
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Outcome(s): Disability