FDA Adverse Event
Injury
Summary report: N
NTI TENSION SUPPRESSION SYSTEM
MDR report key: 5442019
·
Received February 11, 2016
Report
- Report Number
- MW5060227
- Event Type
- Injury
- Date Received
- February 11, 2016
- Date of Event
- February 11, 2016
- Report Date
- February 11, 2016
- Manufacturer
- THERAPEUTIC SOLUTIONS INTERNATIONAL
- Product Code
- LQZ
- Adverse Event
- Yes
- Report Source
- Voluntary report
- Reporter Location
- WI, US
- Reporter Occupation
- PATIENT
Narratives
Description of Event or Problem · 1
PATIENT RECEIVED AN "NTI" SPLINT AND OW HER TEETH ARE SHIFTING AND MOVING EVERYWHERE. ADDITIONALLY, IT DID NOT HELP WITH PAIN AND MADE IT WORSE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 88313 | NTI TENSION SUPPRESSION SYSTEM | NTI TENSION SUPPRESSION SYSTEM | LQZ | THERAPEUTIC SOLUTIONS INTERNATIONAL |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Other |