MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2019-04-23 for SLEEP 8 TRAVEL CPAP CLEANER SLP82043 manufactured by Sleep 8 Inc..
[143027084]
Used a soclean8 cpap cleaner, followed directions for use completely. Started to use my cpap that night, unit had a high level ozone odors present. After about 1/2 hr i had to discontinue using the machine. I had very strong coughing and burning in my lungs and nasal passages. Never had any problems with cpap machine before. Fda safety report id# (b)(4).
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5086082 |
| MDR Report Key | 8544681 |
| Date Received | 2019-04-23 |
| Date of Report | 2019-04-22 |
| Date of Event | 2019-03-29 |
| Date Added to Maude | 2019-04-24 |
| 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 | SLEEP 8 TRAVEL CPAP CLEANER |
| Generic Name | DISINFECTANT, MEDICAL DEVICES |
| Product Code | LRJ |
| Date Received | 2019-04-23 |
| Model Number | SLP82043 |
| Device Availability | Y |
| Device Eval'ed by Mfgr | I |
| Device Sequence No | 0 |
| Device Event Key | 0 |
| Manufacturer | SLEEP 8 INC. |
| Brand Name | SLEEP 8 TRAVEL CPAP CLEANER |
| Generic Name | DISINFECTANT, MEDICAL DEVICES |
| Product Code | LRJ |
| Date Received | 2019-04-23 |
| Model Number | SLP82043 |
| Device Availability | Y |
| Device Eval'ed by Mfgr | I |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | SLEEP8 INC. |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2019-04-23 |