MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2010-05-16 for NEUROMONICS OASIS manufactured by Neuromonics.
[1494629]
Neuromonics oasis: is a device that claims to treat the horrible effects of tinnitus -chronic ringing in the ears-. It is expensive and has not been tested. It's essentially like a (b) (4) with special music from their research and they want it used for at least a few months. I started using this device -they essentially claim it trains the brain not to hear the ringing- and after less than two weeks my tinnitus -which was horrible to begin with- became much, much worse and has remained so since then. They refunded my money but the increased tinnitus has made my everyday life miserable. I began an internet website (b) (6) and have received many similar complaints (b) (6). Thank you. (b) (6). Dates of use: (b) (6) 2008 -- (b) (6) 2008. Diagnosis or reason for use: tinnitus treatment. Event abated after use: no. This is a very dangerous device... And is being marketed to those who suffer from the terrible effects -physical and emotional- of tinnitus.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5016031 |
| MDR Report Key | 1696485 |
| Date Received | 2010-05-16 |
| Date of Report | 2010-05-16 |
| Date of Event | 2008-05-02 |
| Date Added to Maude | 2010-05-26 |
| 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 | 0 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 0 |
| Event Location | 0 |
| Single Use | 0 |
| Previous Use Code | 0 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | NEUROMONICS OASIS |
| Generic Name | NEUROMONICS OASIS |
| Product Code | KLW |
| Date Received | 2010-05-16 |
| Returned To Mfg | 2008-06-05 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | NEUROMONICS |
| Manufacturer Address | PHILADELPHIA PA US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Life Threatening; 2. Other | 2010-05-16 |