MAUDE Adverse Event Report: RESPONSIVE RESPIRATORY INC. PURIFY O3; DISINFECTANT, MEDICAL DEVICES

Model Number 190-6000 PURIFY 03 SANITIZER, XD

Device Problem Patient-Device Incompatibility (2682)

Patient Problems Sneezing (2251); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Date 03/11/2021

Event Type  Injury  

Event Description

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).

• Brand Name: PURIFY O3
• Type of Device: DISINFECTANT, MEDICAL DEVICES
• Manufacturer (Section D): RESPONSIVE RESPIRATORY INC.
• MDR Report Key: 14282692
• MDR Text Key: 290798030
• Report Number: MW5109504
• Device Sequence Number: 1
• Product Code: LRJ
• 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: 04/30/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/03/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: 190-6000 PURIFY 03 SANITIZER, XD
• Was Device Available for Evaluation?: Yes
• Patient Sequence Number: 1
• Treatment: CVS IMMUNE SUPPORT GUMMIES VITAMINS; D3 + K; LEVOTHYROXINE; MAGNESIUM; METOPROLOL. ; WILL RETURN TO USING RESMED CPAP MACHINE
• Patient Outcome(s): Disability
• Patient Age: 68 YR
• Patient Sex: Female
• Patient Ethnicity: Non Hispanic
• Patient Race: White