MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-03-19 for SOCLEAN SC1200 manufactured by Soclean Inc..
[102996599]
After approximately 3 months of using soclean 2 cpap cleaner i noticed i was getting sick, started having chest pains for short periods of time each day and felt tired all the time. After research of the product, found it uses ozone to disinfect and found i had most of the symptoms of excess ozone in my system. After 3 days of not using it i am feeling much better with no instances of chest pain and my cold is going away along with my lungs clearing up. I will be seeing my doctor in 2 weeks to be referred to a cardiologist for assessment.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5075954 |
| MDR Report Key | 7352173 |
| Date Received | 2018-03-19 |
| Date of Report | 2018-03-15 |
| Date of Event | 2018-03-12 |
| Date Added to Maude | 2018-03-20 |
| Event Key | 0 |
| Report Source Code | Voluntary report |
| Manufacturer Link | N |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 0 |
| 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 | SOCLEAN |
| Generic Name | DISINFECTANT, MEDICAL DEVICES |
| Product Code | LRJ |
| Date Received | 2018-03-19 |
| Model Number | SC1200 |
| Operator | LAY USER/PATIENT |
| Device Availability | Y |
| Device Eval'ed by Mfgr | I |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | SOCLEAN INC. |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2018-03-19 |