MAUDE Adverse Event Report: ULTRAVIOLET DISINFECTION LAMP; DISINFECTANT, MEDICAL DEVICES

Device Problems Loose or Intermittent Connection (1371); Defective Component (2292); Material Integrity Problem (2978)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 11/01/2021

Event Description

A reporter called to report about the defective ultraviolet disinfection lamp she bought last year.Reporter bought an ultraviolet disinfection lamp and started using it, and she noticed a whitish powder at the bottom of light bulbs.She threw away that and bought another one.She was having the same problem and more.This one has the whitish powder, and the switches and remote control did not work properly.She said it forced you to look more at the uvc light, which you are not supposed to do since they are harmful for your eyes.She went on saying that the batteries do not have an expiration date.Light bulbs wabble at the top where the lamp is.She said by the time she contacted the vendor, the 30-day warranty had already been expired.She said they only gave her $(b)(6) for the defective device.She said that she was told it works through the walls.However, it does not work through the walls or doors.She said the manufacturer could be medic therapeutics but she is not sure.

• Brand Name: ULTRAVIOLET DISINFECTION LAMP
• Type of Device: DISINFECTANT, MEDICAL DEVICES
• MDR Report Key: 14207599
• MDR Text Key: 290295371
• Report Number: MW5109365
• Device Sequence Number: 2
• Product Code: LRJ
• 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: 04/25/2022
• 2 Devices were Involved in the Event: 1 2

1 Patient was Involved in the Event

• Date FDA Received: 04/25/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Is the Reporter a Health Professional?: No
• Patient Sequence Number: 1
• Patient Age: 72 YR
• Patient Sex: Female
• Patient Weight: 104 KG