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

Device Problem Device Sensing Problem (2917)

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

Event Date 08/18/2022

Event Type  Injury  

Event Description

My partner struggles with severe allergies.In (b)(6) 2022, we bought molekule's air pro air purifier to help alleviate her allergy symptoms.In (b)(6) 2022, the air purifier started to show very high voc readings (volatile organic compounds), signaling that our air quality in the apartment was either "bad" or "very bad." that caused a lot of stress for us and heightened the anxiety of my partner about her allergies.We have been trying in vain to identify the source of the high voc for two months.Eventually we decided to order an indoor air quality analysis by a professional contractor (which cost us about (b)(6)).The analysis showed that our air quality is fine and voc are within the normal range.It appeared that our molekule's air pro was showing incorrect readings to us, mistakenly claiming that our air quality was bad.We took a video where a calibrated and properly functioning air quality device of our contractor is compared side-by-side with molekule air pro.The voc readings of molekule air pro were off by a factor of 10.The co2 readings were off by a factor of 2.When molekule markets its device as "fda-cleared" they say that the device is meant to operate in auto mode.The fan speed is auto mode is adjusted according to the sensor readings.So if the sensor can't correctly measure air quality the fan speed will be either insufficient (not purifying well) or excessive (draining filters faster).Indoor air quality (iaq) and industrial hygiene (ih) testing was conducted by a contractor.Testing was completed for several common iaq parameters, as well as sampling for volatile organic compounds (vocs) using a us epa to-15 solvent scan.Fda safety report id# (b)(4).

• Brand Name: AIR PRO
• Type of Device: PURIFIER, AIR, ULTRAVIOLET, MEDICAL
• Manufacturer (Section D): MOLEKULE, INC.
• MDR Report Key: 15844081
• MDR Text Key: 304289036
• Report Number: MW5113413
• Device Sequence Number: 1
• Product Code: FRA
• 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: 11/17/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/21/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Was Device Available for Evaluation?: Yes
• Patient Sequence Number: 1
• Patient Age: 38 YR
• Patient Sex: Male
• Patient Ethnicity: Non Hispanic
• Patient Race: White