MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2019-04-08 for SOCLEAN 2 CLEANING DEVICE manufactured by Soclean, Inc..
[141442976]
Caller says that the product is used to clean his cpap machine. Caller says that on the side of this nose he gets rough and irritated skin that is painful after using the product. The irritation goes away when he does not use the machine and reappears anytime he uses it. Caller is concerned that the device is damaging his lungs. Retailer: (b)(6). Purchase date: (b)(6) 2018 - this is an estimate. Incident location: (b)(6). (b)(4).
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5085657 |
| MDR Report Key | 8496305 |
| Date Received | 2019-04-08 |
| Date of Report | 2019-04-08 |
| Date of Event | 2018-07-01 |
| Date Added to Maude | 2019-04-09 |
| Event Key | 0 |
| Report Source Code | Voluntary report |
| Manufacturer Link | N |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 0 |
| Product Problem Flag | 0 |
| Reprocessed and Reused Flag | 3 |
| 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 CLEANING DEVICE |
| Generic Name | DISINFECTANT, MEDICAL DEVICES |
| Product Code | LRJ |
| Date Received | 2019-04-08 |
| Model Number | SOCLEAN 2 |
| Device Availability | Y |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | SOCLEAN, INC. |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 0 | 0 | 2019-04-08 |