MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2019-05-13 for SOCLEAN CPAP SANITIZING MACHINE manufactured by Soclean, Inc.
[145279700]
Reporter stated that he uses the soclean cpap cleaner and sanitizer machine and each time he used this machine it produced a gunk like type of substance that gives him headache, bloody nose and respiratory problems. He further reported that each time he sterilizes the machine it goes away for a while and the gunk like substance comes back.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5086620 |
| MDR Report Key | 8608478 |
| Date Received | 2019-05-13 |
| Date of Report | 2019-05-13 |
| Date of Event | 2019-02-01 |
| Date Added to Maude | 2019-05-14 |
| 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 CPAP SANITIZING MACHINE |
| Generic Name | DISINFECTANT, MEDICAL DEVICES |
| Product Code | LRJ |
| Date Received | 2019-05-13 |
| Device Availability | * |
| 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. Required No Informationntervention | 2019-05-13 |