BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PURIFY O3

    MDR report key: 14282692 · Received May 3, 2022

    Report

    Report Number
    MW5109504
    Event Type
    Injury
    Date Received
    May 3, 2022
    Date of Event
    March 11, 2021
    Report Date
    April 30, 2022
    Manufacturer
    RESPONSIVE RESPIRATORY INC.
    Product Code
    LRJ
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    IL, US
    Reporter Occupation
    PATIENT
    Health Professional
    *

    Narratives

    Description of Event or Problem · 0

    I STARTED EACH DAY WITH HORRIBLE, EXTREMELY VOLATILE SNEEZING FITS THAT LEFT ME FEELING TERRIBLE FOR THE REST OF THE DAY. I BEGAN TO SUSPECT THAT IT WAS CAUSED BY USE OF A CPAP MACHINE (RESMED) BUT, MOST LIKELY, IT WAS THE OZONE CLEANING DEVICE TO BLAME. AFTER TOTALLY STOPPING USE OF MY CPAP, THE SNEEZING PROBLEM GRADUALLY SUBSIDED OVER THE COURSE OF A FEW MONTHS. MY PULMONOLOGIST TOLD ME TO STOP USING THE PURIFY 03 OZONE CLEANER. BESIDES HAVING SLEEP APNEA, I WAS ALSO DIAGNOSED WITH IPF LAST (B)(6) 2021. WHAT RECOURSE DO I HAVE? I FEEL THAT THE MANUFACTURER OF PURIFY 03 OZONE CLEANER SHOULD REIMBURSE ME, AT THE VERY LEAST, FOR THE COST OF THE DEVICE. I CAN'T GET BACK ALL THE MONTHS I SUFFERED. FDA SAFETY REPORT ID # (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1378971 PURIFY O3 DISINFECTANT, MEDICAL DEVICES LRJ RESPONSIVE RESPIRATORY INC. 190-6000 PURIFY 03 SANITIZER, XD

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR Female Disability CVS IMMUNE SUPPORT GUMMIES VITAMINS| D3 + K| LEVOTHYROXINE| MAGNESIUM| METOPROLOL. | WILL RETURN TO USING RESMED CPAP MACHINE