MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05 report with the FDA on 2013-06-18 for HERBST manufactured by Allesee Orthodontic Appliances.
[16377247]
The doctor removed the appliance and prescribed a peroxyl rinse for treatment. To date, the patient has fully recovered and is doing fine. A new appliance will be fabricated with consideration to patient comfort.
Patient Sequence No: 1, Text Type: N, H10
[16437977]
A doctor alleged that one (1) patient had experienced irritation and swelling in the roof of her mouth while wearing a herbst appliance.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2184045-2013-00008 |
| MDR Report Key | 3175328 |
| Report Source | 05 |
| Date Received | 2013-06-18 |
| Date of Report | 2013-05-28 |
| Date Mfgr Received | 2013-05-28 |
| Date Added to Maude | 2013-06-18 |
| 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 | 2013-06-18 |
| ID Number | WO #7444349 |
| 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 | 2013-06-18 |