MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2019-02-27 for SOCLEAN2 CPAP SANITIZING MACHINE manufactured by Soclean, Inc.
[137554718]
I purchased a soclean2 pap disinfecting device on (b)(6) 2018, from (b)(6) center in (b)(6), to clean my cpap unit. Since using the product from that time, i have noticed my sense of taste and smell have diminished dramatically as well as a very dry and an unusual taste in my mouth. Everything i eat tastes bland. Can you tell me if this product has side effects that are causing me these issues? I have not changed anything else in my diet. Including no new medications. Is there residue left from the cleaning that are irritating my mucous membranes? I have appointments to see a pulmonary and nose/throat specialist as well as my dentist to rule out any other medical issues. As i mentioned before, there have been no changes to my diet or lifestyle and current blood tests show no issues.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5084463 |
| MDR Report Key | 8377760 |
| Date Received | 2019-02-27 |
| Date of Report | 2019-02-25 |
| Date of Event | 2019-02-20 |
| Date Added to Maude | 2019-02-28 |
| 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 CPAP SANITIZING MACHINE |
| Generic Name | DISINFECTANT MEDICAL DEVICES |
| Product Code | LRJ |
| Date Received | 2019-02-27 |
| Model Number | SOCLEAN2 |
| 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. Other | 2019-02-27 |