MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2016-09-20 for SOCLEAN 2 manufactured by Inceptus.
[55445985]
I purchased a soclean c-pap-cleaner. I followed all of the directions i. E. , preached the unit, hoses etc. I then cleaned the cpap machine using soclean at the recommended settings. That evening i slept with the cleaned machine. The smell of ozone was strong. The mfr calls ozone activated oxygen. After about 6 hours, i experienced a severe asthma attack which i have never had before. Treatment with rescue inhaler, steroids, bronchodilators. I have cough predominant asthma. The coughing was so severe that i injured my back.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5064944 |
| MDR Report Key | 5969746 |
| Date Received | 2016-09-20 |
| Date of Report | 2016-09-20 |
| Date of Event | 2016-09-10 |
| Date Added to Maude | 2016-09-22 |
| 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 2 |
| Generic Name | SOCLEAN 2 |
| Product Code | LRJ |
| Date Received | 2016-09-20 |
| Model Number | SOCLEAN 2 |
| Operator | LAY USER/PATIENT |
| Device Availability | Y |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | INCEPTUS |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other; 2. Required No Informationntervention | 2016-09-20 |