MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05 report with the FDA on 2008-12-05 for TRANS-PALATAL ARCH (TPA) APPLIANCE manufactured by Allesee Orthodontic Appliances.
[1004553]
In 2008, a doctor reported that a patient had developed a blueish discoloration on his palatal tissue in his mouth from wearing the trans-palatal arch (tpa) appliance.
Patient Sequence No: 1, Text Type: D, B5
[8132006]
The doctor reported that the patient's pediatric dentist noticed the blueish discoloration during a routine check-up. The dentist observed the discoloration for two weeks and believes it is harmless to the patient. The doctor reported that it appears to be a type of permanent tattoo (similar to an amalgam tattoo) isolated to where the solder of the stainless steel appliance was in contact with the patient's palatal tissue. According to the doctor the discoloration is harmless and since it is only visible inside the patient's mouth on the inner palatal tissue, it does not create any aesthetic problems for the patient. The patient is doing fine and has had the appliance removed since 2008. The patient wore the appliance for approximately four years. This is the final report.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2184045-2008-00003 |
| MDR Report Key | 1251343 |
| Report Source | 05 |
| Date Received | 2008-12-05 |
| Date of Report | 2008-11-10 |
| Date Mfgr Received | 2008-11-10 |
| Device Manufacturer Date | 2004-03-16 |
| Date Added to Maude | 2008-12-30 |
| 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 | 2008-12-05 |
| ID Number | WO #1854592 |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Implant Flag | N |
| Date Removed | B |
| Device Sequence No | 1 |
| Device Event Key | 1305037 |
| Manufacturer | ALLESEE ORTHODONTIC APPLIANCES |
| Manufacturer Address | 13931 SPRING STREET STURTEVANT WI 53177 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2008-12-05 |