MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05 report with the FDA on 2014-07-08 for HERBST manufactured by Allesee Orthodontic Appliances.
[4665686]
A doctor alleged that a patient had developed sores on the upper and lower right cheek while wearing a herbst appliance.
Patient Sequence No: 1, Text Type: D, B5
[12125731]
Patient specifics with regard to age and weight were not provided. The doctor removed the appliance and prescribed antibiotics for treatment. To date, the patient has fully recovered and is doing fine. A new appliance will be fabricated with consideration to the patient comfort. An evaluation of the returned device is anticipated, but has not yet begun.
Patient Sequence No: 1, Text Type: N, H10
[23101645]
The returned appliance was evaluated against a new model of the patient's mouth and it was confirmed that the appliance does not fit. It was discovered that the lower jaw cantilevers and the upper jaw extended tube on the right side had protruded too far buccally. A new appliance will be fabricated with regard to patient comfort.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2184045-2014-00002 |
| MDR Report Key | 3919834 |
| Report Source | 05 |
| Date Received | 2014-07-08 |
| Date of Report | 2014-06-10 |
| Date Mfgr Received | 2014-06-10 |
| Date Added to Maude | 2014-07-09 |
| 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 | MRS. KERRI CASINO |
| Manufacturer Street | 1717 W COLLINS AVE |
| Manufacturer City | ORANGE CA 92867 |
| Manufacturer Country | US |
| Manufacturer Postal | 92867 |
| Manufacturer Phone | 7145167634 |
| 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 | 2014-07-08 |
| ID Number | WO #7667774 |
| Operator | OTHER |
| Device Availability | Y |
| Device Age | DA |
| 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; 2. Required No Informationntervention | 2014-07-08 |