FDA Adverse Event
Injury
Summary report: N
POSITIONER
MDR report key: 2411463
·
Received January 11, 2012
Report
- Report Number
- 2184045-2012-00001
- Event Type
- Injury
- Date Received
- January 11, 2012
- Date of Event
- July 18, 2011
- Report Date
- December 13, 2011
- Manufacturer
- ALLESEE ORTHODONTIC APPLIANCES
- Product Code
- KMY
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- IL, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
THE PATIENT CONFIRMED OVER THE PHONE THAT SHE IS IMPROVING, BUT SHE STILL CANNOT OPEN HER JAW PROPERLY AND CANNOT CHEW PROPERLY. MODIFICATIONS TO THE EXISTING APPLIANCE WILL BE MADE WITH REGARD TO PATIENT COMFORT.
Description of Event or Problem · 1
ON (B)(6), 2011, A DOCTOR ALLEGED THAT THE POSITIONER APPLIANCE CAUSED A PATIENT TO HAVE TMJ ISSUES. THE PATIENT STOPPED WEARING THE APPLIANCE AND IS RECOVERING. THE PATIENT IS TAKING MOTRIN FOR PAIN RELIEF.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | POSITIONER | POSITIONER, TOOTH, PREFORMED | KMY | ALLESEE ORTHODONTIC APPLIANCES |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Other | MOTRIN |