MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05 report with the FDA on 2013-01-10 for HERBST manufactured by Allesee Orthodontic Appliances.
[3304250]
A doctor alleged that a patient had experienced irritation of the tongue due to the position of the tpa wire on the herbst device.
Patient Sequence No: 1, Text Type: D, B5
[10449424]
The appliance was removed and the patient was prescribed an antibiotic ointment (lysine) and an oral rinse solution (peroxyl) for treatment. A new appliance was fabricated and has been placed, without further incident. To date, the patient is doing fine and has fully recovered.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2184045-2013-00001 |
| MDR Report Key | 2908503 |
| Report Source | 05 |
| Date Received | 2013-01-10 |
| Date of Report | 2012-12-13 |
| Date Mfgr Received | 2012-12-13 |
| Device Manufacturer Date | 2012-11-21 |
| Date Added to Maude | 2013-01-11 |
| 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 | MRS. WENDY GARMAN |
| Manufacturer Street | 1717 WEST COLLINS AVENUE |
| Manufacturer City | ORANGE CA 92867 |
| Manufacturer Country | US |
| Manufacturer Postal | 92867 |
| Manufacturer Phone | 7145167602 |
| 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 | HERBST |
| Generic Name | BITE-JUMPING ORTHODONTIC APPLIANCE |
| Product Code | EJF |
| Date Received | 2013-01-10 |
| ID Number | WO# 7442707 |
| 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; 2. Required No Informationntervention | 2013-01-10 |