MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2015-07-17 for NEUROMONICS OASIS TINNITUS DEVICE OID-00000620 manufactured by Neuromonics Inc.
[17938446]
Neuromonics oasis tinnitus device causing bilateral inner-ear pressure and worsening tinnitus, as well as worsening hypoacusis. Device of no benefit and appears to be causing harm. Worsening hyperacusis and tinnitus with use of neuromonics oasis tinnitus treatment device. Also causing severe inner ear pressure bilateral. Not effective, of no benefit, and causing harm. Dose, frequency and route used: daily 10 min to 2 hrs. Bilateral ears listening. Therapy dates: daily since (b)(6) 2015.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5044715 |
| MDR Report Key | 4939120 |
| Date Received | 2015-07-17 |
| Date of Report | 2015-07-13 |
| Date of Event | 2015-05-26 |
| Date Added to Maude | 2015-07-27 |
| Event Key | 0 |
| Report Source Code | Voluntary report |
| Manufacturer Link | N |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 0 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Reporter Occupation | PATIENT |
| 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 TINNITUS DEVICE |
| Generic Name | OASIS |
| Product Code | KLW |
| Date Received | 2015-07-17 |
| Model Number | OID-00000620 |
| Operator | LAY USER/PATIENT |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | NEUROMONICS INC |
| Manufacturer Address | 8774 YATES DR UNIT 220 WESTMINSTER CO 80031 US 80031 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2015-07-17 |