MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2020-03-24 for VIRTUCLEAN OZONE BASED CPAP CLEANER XD1001731058 manufactured by Healthcare Logistics Systems.
[185005899]
I have been coughing fairly consistently following the use of an ozone cleaner for my cpap about 4 months now. Well before covid-19. Feel fine most of day, cough in the morning - throat clearing type of cough and then late in the evenings. I did not know ozone cpap cleaners were not fda approved. This should be advertised. Fda safety report id# (b)(4).
Patient Sequence No: 1, Text Type: D, B5
Report Number | MW5093905 |
MDR Report Key | 9877293 |
Date Received | 2020-03-24 |
Date of Report | 2020-03-23 |
Date of Event | 2020-03-23 |
Date Added to Maude | 2020-03-25 |
Event Key | 0 |
Report Source Code | Voluntary report |
Manufacturer Link | N |
Number of Patients in Event | 0 |
Adverse Event Flag | 3 |
Product Problem Flag | 3 |
Reprocessed and Reused Flag | 3 |
Reporter Occupation | PATIENT |
Health Professional | 3 |
Initial Report to FDA | 3 |
Report to FDA | 3 |
Event Location | 3 |
Single Use | 3 |
Previous Use Code | 3 |
Event Type | 3 |
Type of Report | 3 |
Brand Name | VIRTUCLEAN OZONE BASED CPAP CLEANER |
Generic Name | DISINFECTANT, MEDICAL DEVICES |
Product Code | LRJ |
Date Received | 2020-03-24 |
Model Number | XD1001731058 |
Operator | LAY USER/PATIENT |
Device Availability | Y |
Device Eval'ed by Mfgr | I |
Device Sequence No | 1 |
Device Event Key | 0 |
Manufacturer | HEALTHCARE LOGISTICS SYSTEMS |
Patient Number | Treatment | Outcome | Date |
---|---|---|---|
1 | 0 | 2020-03-24 |