• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

MAUDE Adverse Event Report: OZONE CLEANERS DISINFECTANT, MEDICAL DEVICES

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

OZONE CLEANERS DISINFECTANT, MEDICAL DEVICES Back to Search Results
Device Problems Nonstandard Device (1420); Patient-Device Incompatibility (2682)
Patient Problems Asthma (1726); Dyspnea (1816); Forced Expiratory Volume Decreased (2430)
Event Date 06/16/2021
Event Type  Injury  
Event Description
I was diagnosed with asthma and prescribed flovent and albuterol inhalers. I have never had respiratory problems in my life. I was notified by respironics that the cpap machine i was using, dreamstation, was recalled due to a foam within the machine for sound abatement degrading and being released into the air pathway and can be inhaled. It may be exacerbated by use of ozone cleaners which i used for about 3 months. One of the side effects is irritation of the respiratory tract, cough, and asthma. I began having shortness of breath with exercise and difficulty exhaling. I do have a congenital heart defect and have had surgery. But my cardiologist has performed tests and determined that these symptoms were not heart related. I had pulmonary function tests done and it was abnormal. My expiratory volume/pressure was abnormal. I am followed by a pulmonologist. The cpap machine has helped very much with my sleep as i used to wake up with headaches every day. However i am afraid to continue using it. I feel it could be contributing to my respiratory problems. There is moderate decrease in fev1 and fvc with normal tlc suggesting a moderate obstructive ventilatory defect. Normal diffusion capacity and non specific airway resistance pattern is notes. Fda safety report id # (b)(4).
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand NameOZONE CLEANERS
Type of DeviceDISINFECTANT, MEDICAL DEVICES
MDR Report Key12481008
MDR Text Key272118836
Report NumberMW5103986
Device Sequence Number2
Product Code LRJ
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Voluntary
Reporter Occupation Patient
Type of Report Initial
Report Date 09/13/2021
2 Devices were Involved in the Event: 1   2  
1 Patient was Involved in the Event
Date FDA Received09/15/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Was Device Available for Evaluation? No Answer Provided
Is the Reporter a Health Professional? No Answer provided
Was the Report Sent to FDA?
Event Location No Information
Was Device Evaluated by Manufacturer?
Is the Device Single Use?
Is This a Reprocessed and Reused Single-Use Device?
Type of Device Usage

Patient Treatment Data
Date Received: 09/15/2021 Patient Sequence Number: 1
-
-