MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 08 report with the FDA on 2012-01-07 for DISTAL JET manufactured by Allesee Orthodontic Appliances.
[2417673]
On (b)(6), 2011, a doctor alledged that a patient possibly had an allergic reaction to the distal jet appliance.
Patient Sequence No: 1, Text Type: D, B5
[9597269]
The doctor prescribed an antibiotic and benadryl for the alleged allergic reaction. To date, the patient is doing fine and has fully recovered. A new appliance will be remade with a different material with regard to patient comfort.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2184045-2012-00003 |
| MDR Report Key | 2403077 |
| Report Source | 08 |
| Date Received | 2012-01-07 |
| Date of Report | 2011-12-09 |
| Date Mfgr Received | 2011-12-09 |
| Date Added to Maude | 2012-01-09 |
| 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 | DISTAL JET |
| Generic Name | RETAINER, SCREW EXPANSION, ORTHODONTIC |
| Product Code | DYJ |
| Date Received | 2012-01-07 |
| ID Number | WORK ORDER# 3459185 |
| Operator | OTHER |
| 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 | 2012-01-07 |