MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a * report with the FDA on 2014-06-18 for TMJ DENTAL DEVICE manufactured by Unknown.
[4589585]
Mri procedure called for radiologist tech to insert object into my mouth with a piece of wax that would hold my jaw when in this position ie manipulated for the mri. Upon directive to close onto object, my whole entire left jaw was yanked out of my head and made to propel downwards and with a thud locked. This orthotic has no objective data supporting it use trial or otherwise and should be banned and patients not subjected to trials on device that is unknown not tested has no data and produced an injury to my tmj destroying the right one, so now inoperable and mangling the left tmj. The instructions for insert of this object were irregular and the dental device had no data preceding and thus no accountability. This hazardous product should not have been blindly inserted into my mouth with a manipulated hold by a well versed tech who was confused about the instructions. People aren't cadavers and both tmjs are seriously injured due to a test of a defective product! (b)(4).
Patient Sequence No: 1, Text Type: D, B5
[36722100]
(b)(4). It is incorrectly classified under tooth resins. Nothing to do with that. Was the improper testing in mri of unorthodox tmj splint combined by restraint into fixed position or hold that caused maximum joint dislocation to occur.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5036668 |
| MDR Report Key | 3881923 |
| Report Source | * |
| Date Received | 2014-06-18 |
| Date of Report | 2014-06-19 |
| Date of Event | 2014-04-25 |
| Date Added to Maude | 2014-06-18 |
| 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 | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | TMJ DENTAL DEVICE |
| Product Code | BRW |
| Date Received | 2014-06-18 |
| Device Availability | * |
| Device Age | DA |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | UNKNOWN |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other; 2. Deathisabilit | 2014-06-18 |