MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2015-02-20 for NEUROMONICS OASIS manufactured by Neuromonics Inc..
[15106042]
The reporter stated that she was suffering from tinnitus in her right ear. Her audiologist prescribed neuromonics oasis to alleviate the symptoms. The reporter stated that she suffered from adverse effect using the device. She is experiencing loud screeching noises and the pitch was very loud. After wearing the device, both of her ears became affected. The reporter also complained that her audiologist did not give her a prescription for the device. The reporter stated as a result fo this condition, she has not been able to function normally for the past thirteen months. She has stopped working, and has not been able to go to public places since the surrounding noise is too loud for her.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5040884 |
| MDR Report Key | 4541670 |
| Date Received | 2015-02-20 |
| Date of Report | 2015-02-20 |
| Date of Event | 2014-01-01 |
| Date Added to Maude | 2015-02-25 |
| Event Key | 0 |
| Report Source Code | Voluntary report |
| Manufacturer Link | N |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 0 |
| Reprocessed and Reused Flag | 0 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 0 |
| Event Location | 3 |
| 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 | 2015-02-20 |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | NEUROMONICS INC. |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Deathisabilit | 2015-02-20 |