MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2004-10-01 for NTI-TSS * manufactured by Nti-tss.
[376008]
The nti-tss is a device intended to prevent bruxism -grinding of teeth- and clenching. It is intended to be worn primarily at night. Pt's dentist fabricated one of these devices. Upon expression of concern to him, he kindly refunded the entire cost of the device. Pt's concern is that this device poses a signficant threat of death by choking. The nti-tss measures no more that 3/4" -. 75 inches- in any dimension. The consumer products safety commission guideline for a choking hazard is an object under 1. 75 inches in diameter. The nti-tss is less than half this wide. Although the mfr claims that there were no incidents of the devices being dislodged, in fact this could easily happen. A user could dislodge the nti-tss with the tongue, or, during sleep, unconsciously reach into the mouth to loosen or readjust it -it is very uncomfortable-. If it remained in the mouth it could easily become lodged in the throat.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW1033575 |
| MDR Report Key | 557167 |
| Date Received | 2004-10-01 |
| Date of Report | 2004-10-01 |
| Date Added to Maude | 2004-12-02 |
| 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 | 3 |
| Reporter Occupation | PATIENT |
| Health Professional | 3 |
| Initial Report to FDA | 0 |
| Report to FDA | 0 |
| Event Location | 3 |
| Single Use | 0 |
| Previous Use Code | 0 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | NTI-TSS |
| Generic Name | TENSION SUPPRESSION SYSTEM FOR BRUXISM |
| Product Code | LQZ |
| Date Received | 2004-10-01 |
| Model Number | * |
| Catalog Number | * |
| Lot Number | ITEM IS CUSTOM MFRD |
| ID Number | * |
| Operator | LAY USER/PATIENT |
| Device Availability | Y |
| Implant Flag | N |
| Date Removed | * |
| Device Sequence No | 1 |
| Device Event Key | 546841 |
| Manufacturer | NTI-TSS |
| Manufacturer Address | * MISHAWAKA IN 46544 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Life Threatening | 2004-10-01 |