MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2019-04-25 for SOCLEAN2 SC1200 manufactured by Soclean, Inc..
[143400900]
Purchased "soclean" for use with cpap. Had a small cut on nose. When using the "soclean" to sanitize my cpap, i developed oozing sores on my nose, similar to cold sores. When i traveled for a week and continued to use the cpap but not the "soclean", the sores cleared up. Returned home and used "soclean" and the sores returned. Was on vacation for 2 weeks and the sores cleared up. I returned home and started using the "so clean" and they returned. I can only conclude that it is the "soclean" because i continue to use the cpap when i travel but not the soclean and the sores clear up. Fda safety report id# (b)(4).
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5086202 |
| MDR Report Key | 8555625 |
| Date Received | 2019-04-25 |
| Date of Report | 2019-04-23 |
| Date of Event | 2019-03-09 |
| Date Added to Maude | 2019-04-26 |
| 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 | DISINFECTANT, MEDICAL DEVICES |
| Product Code | LRJ |
| Date Received | 2019-04-25 |
| 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 | SOCLEAN, INC. |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Deathisabilit | 2019-04-25 |