MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05 report with the FDA on 2010-08-13 for DISTAL JET TADS APPLIANCE manufactured by Allesee Orthodontic Appliances.
[1530091]
On (b)(6) 2010, a doctor reported that a patient developed an infection in her mouth, due to irritation caused by a distal jet tads appliance.
Patient Sequence No: 1, Text Type: D, B5
[8668381]
The doctor stated that amoxicillin, tylenol with codeine, and peridex were all prescribed to treat the infection and discomfort that a patient experienced as a result of irritation caused by the appliance. The infection has healed completely and the patient is doing fine. The appliance was not returned for evaluation. It is uncertain as to whether or not a new appliance will be placed.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2184045-2010-00005 |
| MDR Report Key | 1798939 |
| Report Source | 05 |
| Date Received | 2010-08-13 |
| Date of Report | 2010-07-15 |
| Date Mfgr Received | 2010-07-15 |
| Device Manufacturer Date | 2010-03-30 |
| Date Added to Maude | 2010-08-13 |
| 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 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 | DISTAL JET TADS APPLIANCE |
| Generic Name | RETAINER, SCREW EXPANSION, ORTHODONTIC |
| Product Code | DYJ |
| Date Received | 2010-08-13 |
| ID Number | WORK ORDER# 3121263/3183301 |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| 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 | 2010-08-13 |