MAUDE Adverse Event Report: OZINATING UVC GERMICIDAL LAMP; DEVICE, GERMICIDAL, ULTRAVIOLET

Device Problem Patient-Device Incompatibility (2682)

Patient Problems Respiratory Distress (2045); Visual Disturbances (2140)

Event Date 04/21/2020

Event Type  Injury  

Event Description

I have vision damage from ozonating uvc light similar to (b)(6) product also respiratory issues.Fda safety report id# (b)(4).

• Brand Name: OZINATING UVC GERMICIDAL LAMP
• Type of Device: DEVICE, GERMICIDAL, ULTRAVIOLET
• MDR Report Key: 10086833
• MDR Text Key: 192185000
• Report Number: MW5094667
• Device Sequence Number: 1
• Product Code: MKB
• Combination Product (y/n): N
• 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: 05/20/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/22/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Was Device Available for Evaluation?: No
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention; Disability
• Patient Age: 36 YR
• Patient Weight: 82