BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AIR PRO

    MDR report key: 15844081 · Received November 21, 2022

    Report

    Report Number
    MW5113413
    Event Type
    Injury
    Date Received
    November 21, 2022
    Date of Event
    August 18, 2022
    Report Date
    November 17, 2022
    Manufacturer
    MOLEKULE, INC.
    Product Code
    FRA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    MA, US
    Reporter Occupation
    PATIENT
    Health Professional
    *

    Narratives

    Description of Event or Problem · 0

    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).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2707887 AIR PRO PURIFIER, AIR, ULTRAVIOLET, MEDICAL FRA MOLEKULE, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 38 YR Male