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U.S. Department of Health and Human Services

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

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3B MEDICAL, INC. LUMIN BULLET DISINFECTANT, MEDICAL DEVICES Back to Search Results
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).
 
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Brand NameLUMIN BULLET
Type of DeviceDISINFECTANT, MEDICAL DEVICES
Manufacturer (Section D)
3B MEDICAL, INC.
MDR Report Key11364949
MDR Text Key233314756
Report NumberMW5099542
Device Sequence Number1
Product Code LRJ
Reporter Country CodeUS
Number of Events Reported1
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
0 Patients were Involved in the Event:
Date FDA Received02/22/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? No Answer provided
Was the Report Sent to FDA?
Event Location No Information
Was Device Evaluated by Manufacturer?
Is the Device Single Use?
Is This a Reprocessed and Reused Single-Use Device?
Type of Device Usage

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