MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-08-21 for SOCLEAN CPAP CLEANING MACHINE manufactured by Soclean Inc..
[118037108]
I used the soclean cpap cleaning machine, after i purchased it for (b)(6). It used ozone to cleanse cpap machine. There was ozone residue left in my cpap after using the soclean, and that ozone residue burned my sinuses and lungs. This product is hazardous to people's respiratory systems and it causes pain. It caused me severe pain. This product is unregulated and it should be regulated. I went to the doctor and was told to discontinue use of the soclean machine.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5079283 |
| MDR Report Key | 7805317 |
| Date Received | 2018-08-21 |
| Date of Report | 2018-08-18 |
| Date of Event | 2017-05-01 |
| Date Added to Maude | 2018-08-22 |
| 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 | 0 |
| Brand Name | SOCLEAN CPAP CLEANING MACHINE |
| Generic Name | DISINFECTANT, MEDICAL DEVICES |
| Product Code | LRJ |
| Date Received | 2018-08-21 |
| Operator | LAY USER/PATIENT |
| Device Availability | N |
| Device Eval'ed by Mfgr | I |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | SOCLEAN INC. |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Deathisabilit | 2018-08-21 |