MAUDE Adverse Event Report: MOLEKULE INC. AIR MINI; PURIFIER, AIR, ULTRAVIOLET, MEDICAL

Model Number MN1B-US

Device Problems Use of Device Problem (1670); Improper or Incorrect Procedure or Method (2017); Inadequate Instructions for Non-Healthcare Professional (2956); Device Difficult to Maintain (3134)

Patient Problem Insufficient Information (4580)

Event Date 05/21/2021

Event Type  malfunction  

Event Description

Purchased an air mini from molekule because it is marketed as a medical device.While reading the manual provided with the product, i had some questions on used filters disposal and cleaning so i contacted customer service.Page 5 states to "contact your healthcare provider for biohazard bags and containment recommendations" the cs person said its ok to just put it in the trash.No special handling is required.When i pointed out the manual was very specific on how to handle disposing of the filter and this is completely different than the manual.I expressed by concern about contaminants going into the air.The csr said its nothing to be concerned with.My second question was on cleaning.Page 7 says to wipe external surfaces only per standard surface cleaning procedures, which none are stated.I asked the csr about these cleaning procedures and was told, just to wipe it with a damp cloth.I expressed concern about this as how will a damp cloth control and bacteria or viruses which may be on the product surfaces.The csr said they are captured by the filter so wiping is all that is necessary.When i explained that the product has lots of surface area that could hold bacteria or viruses before getting to the filter.I was then told that wiping with a damp cloth would take care of any bacteria or viruses.Told her nicely that i think she is wrong.If a simple damp cloth would eliminate bacteria and viruses, why are companies like lysol still in business.I told her (csr) that i am uncomfortable with her telling me to ignore the manual and do what she says.I expressed my concern that doing what she said could put my health or others in my family at risk.Her response was its not a problem.Told the csr i had one more question regarding the led's.In the faq section is stated "the led's are designed to last the life of the device".I asked what is the life of the product.Her answer was it comes with a two year warranty.I said, i know this from the manual but what is the life of the product so i know when to stop using it.All she could tell me is it lasts a long time.I expressed concern as i know led output decreases over time and how would i know if the peco technology is still working.She could not provide an answer.I am ending our call by telling the csr, i am concerned about the product use and safety given everything she told me.Fda safety report id # (b)(4).

• Brand Name: AIR MINI
• Type of Device: PURIFIER, AIR, ULTRAVIOLET, MEDICAL
• Manufacturer (Section D): MOLEKULE INC.
• MDR Report Key: 11885334
• MDR Text Key: 253522389
• Report Number: MW5101548
• Device Sequence Number: 1
• Product Code: FRA
• UDI-Device Identifier: 00818701020520
• UDI-Public: 00818701020520
• 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: 05/24/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/25/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: MN1B-US
• Was Device Available for Evaluation?: Yes
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 65 YR
• Patient Weight: 127