MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05 report with the FDA on 2012-01-11 for POSITIONER manufactured by Allesee Orthodontic Appliances.
[17881897]
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.
Patient Sequence No: 1, Text Type: D, B5
[18024024]
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.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2184045-2012-00001 |
| MDR Report Key | 2411463 |
| Report Source | 05 |
| Date Received | 2012-01-11 |
| Date of Report | 2011-12-13 |
| Date of Event | 2011-07-18 |
| Date Mfgr Received | 2011-12-13 |
| Date Added to Maude | 2012-01-12 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 0 |
| Event Location | 0 |
| Manufacturer Contact | MR. ORLANDO TADEO, JR. |
| Manufacturer Street | 1717 W. COLLINS AVE. |
| Manufacturer City | ORANGE CA 92867 |
| Manufacturer Country | US |
| Manufacturer Postal | 92867 |
| Manufacturer Phone | 7145167419 |
| Manufacturer G1 | ALLESEE ORTHODONTIC APPLIANCES |
| Manufacturer Street | 13931 SPRING STREET |
| Manufacturer City | STURTEVANT WI 53177 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 53177 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | POSITIONER |
| Generic Name | POSITIONER, TOOTH, PREFORMED |
| Product Code | KMY |
| Date Received | 2012-01-11 |
| ID Number | WO # 3406696 |
| Operator | OTHER |
| Device Availability | Y |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | ALLESEE ORTHODONTIC APPLIANCES |
| Manufacturer Address | 13931 SPRING STREET STURTEVANT WI 53177 US 53177 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2012-01-11 |