MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05 report with the FDA on 2011-06-03 for TRANS-PALATAL ARCH (TPA) APPLIANCE manufactured by Allesee Orthodontic Appliances.
[2144214]
On (b)(6) 2011, a doctor reported that a patient's trans-palatal arch (tpa) appliance caused cuts in her tongue.
Patient Sequence No: 1, Text Type: D, B5
[9025049]
Vicodin was prescribed for pain and an oral rinse was administered for treatment. The patient has fully recovered. Adjustments were made to the appliance and will be placed. Since each appliance is custom-made to the request of the prescription, there was no product problem.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2184045-2011-00003 |
| MDR Report Key | 2113947 |
| Report Source | 05 |
| Date Received | 2011-06-03 |
| Date of Report | 2011-05-04 |
| Date Mfgr Received | 2011-05-04 |
| Date Added to Maude | 2011-06-06 |
| 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 | TRANS-PALATAL ARCH (TPA) APPLIANCE |
| Generic Name | RETAINER, SCREW EXPANSION, ORTHODONTIC |
| Product Code | DYJ |
| Date Received | 2011-06-03 |
| ID Number | WO# 3333372 |
| Device Availability | N |
| 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 | 2011-06-03 |