MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2017-09-15 for SO CLEAN manufactured by Soclean.
[86589515]
My husband had started using a so clean brand cpap sanitizer for several months. He had developed a cough and then difficulty which kept getting worse over 3 months. He developed pneumonia, which was treated but he still had the same symptoms. He had pulmonary function tests, was treated with inhalers, ppls for reflux. He didn't improve and this was ongoing for months. I started reading about ozone residue from soclean and had him discontinue the soclean and change his tubing and mask and he started to improve in 3-4 days and continued to improve over the next 3 weeks. It's now three months later and those symptoms haven't recurred. He has not retried the soclean.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5072184 |
| MDR Report Key | 6872028 |
| Date Received | 2017-09-15 |
| Date of Report | 2017-09-14 |
| Date of Event | 2017-02-15 |
| Date Added to Maude | 2017-09-18 |
| 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 FAMILY MEMBER OR FRIEND |
| 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 | SO CLEAN |
| Generic Name | DISINFECTANT MEDICAL DEVICE |
| Product Code | LRJ |
| Date Received | 2017-09-15 |
| Operator | LAY USER/PATIENT |
| Device Availability | Y |
| Device Eval'ed by Mfgr | I |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | SOCLEAN |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other; 2. Deathisabilit | 2017-09-15 |