MAUDE Adverse Event Report: 3B MEDICAL, INC. LUMIN BULLET; DISINFECTANT, MEDICAL DEVICES

Device Problem Protective Measures Problem (3015)

Patient Problem Insufficient Information (4580)

Event Date 01/01/2021

Event Type  malfunction  

Event Description

Hello, i am a cpap machine user and i have stumbled across a dangerous third party cleaning machine.I don't want to hurt this company because their main product is a huge blessing to me.The product is called the lumin bullet and was designed to clean sleep apnea tubes with uv light.However, when the inner "bullet" is charged and sitting outside the protect case - the magnet inside the device can pull the "bullet" to the outside of the device and active the uv light directly exposed.It happened once to me and i quickly looked away.For a medical device company, this seems like a surprising flaw of safety and well being.If you need a clearer picture, i can email again or send a video.I will need to get some uv protected glasses first.Fda safety report id# (b)(4).

• Brand Name: LUMIN BULLET
• Type of Device: DISINFECTANT, MEDICAL DEVICES
• Manufacturer (Section D): 3B MEDICAL, INC.
• MDR Report Key: 11364949
• MDR Text Key: 233314756
• Report Number: MW5099542
• Device Sequence Number: 1
• Product Code: LRJ
• 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: 02/18/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 02/22/2021
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 33 YR
• Patient Weight: 145