MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2010-03-02 for NTI TENSION SUPPRESSION SYSTEM manufactured by Nti.
[18916535]
Prescribed the nti-tss device and is experiencing severe dizziness, ear pain and swelling, and vision issues. It is difficult to go about daily activities with these symptoms. Teeth on left side of mouth touch while teeth on right are not. Dentists and ent doctors don't know what to do and are unable to help.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5015011 |
| MDR Report Key | 1623652 |
| Date Received | 2010-03-02 |
| Date of Report | 2010-03-02 |
| Date of Event | 2010-02-06 |
| Date Added to Maude | 2010-03-17 |
| 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 |
| Reporter Occupation | PATIENT |
| 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 | NTI TENSION SUPPRESSION SYSTEM |
| Generic Name | NTI-TSS |
| Product Code | LQZ |
| Date Received | 2010-03-02 |
| Operator | LAY USER/PATIENT |
| Device Availability | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | NTI |
| Manufacturer Address | MISHAWAKA IN US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2010-03-02 |