MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-04-27 for SOCLEAN2 SC1200 manufactured by Unk.
[107069439]
Purchased a soclean 2 cpap sanitizer from apria direct health care. Upon using machine a strong odor was noted on mask, but was told this was normal and that it was like the ocean smell. After the first week i began having trouble with my breathing. It continued to get worse. Started breathing treatments and prednisone did not help. I then found out that they used ozone to sanitize the cpap machine. Checked the (b)(6) clinic web site only to find ozone is an irritant and can cause asthma attacks. Called apira direct and they told me to return the machine. They do not advise you of this danger. I ended up in an urgent care center today for the asthma attack.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5076894 |
| MDR Report Key | 7472673 |
| Date Received | 2018-04-27 |
| Date of Report | 2018-04-14 |
| Date of Event | 2018-03-12 |
| Date Added to Maude | 2018-04-30 |
| 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 | SOCLEAN2 |
| Generic Name | CPAP SANITIZER |
| Product Code | LRJ |
| Date Received | 2018-04-27 |
| 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 | UNK |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other; 2. Deathisabilit | 2018-04-27 |