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 |