MAUDE Adverse Event Report: IN LIGHT WELLNESS SYSTEMS IN LIGHT WELLNESS SYSTEM; THERAPEUTIC HEATING LAMP

Device Problem Device Operates Differently Than Expected (2913)

Patient Problems Unspecified Infection (1930); Keratitis (1944)

Event Date 12/30/2016

Event Type  Injury  

Event Description

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.

• Brand Name: IN LIGHT WELLNESS SYSTEM
• Type of Device: THERAPEUTIC HEATING LAMP
• Manufacturer (Section D): IN LIGHT WELLNESS SYSTEMS
• MDR Report Key: 6294201
• MDR Text Key: 66383554
• Report Number: MW5067595
• Device Sequence Number: 1
• Product Code: ILY
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Patient
• Type of Report: Initial
• Report Date: 01/30/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/30/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Treatment: OTC MEDS: NA; RX MEDS: NA
• Patient Outcome(s): Disability
• Patient Age: 67 YR
• Patient Weight: 99