MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05 report with the FDA on 2008-02-19 for HERBST APPLIANCE manufactured by Allesee Orthodontic Appliances.
[793698]
In 2008, a dr alleged that a pt developed an infection due to irritation from wearing the herbst appliance.
Patient Sequence No: 1, Text Type: D, B5
[8091866]
The product was irritating the pt's cheek. In 2008, the pt was seen by an oral surgeon who prescribed kenalog in orabase to help heal the cheek irritation. During this time the pt developed a fibroma (scar tissue) which the dr stated will be removed. The pt will be fitted with a different appliance at her next appointment.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2184045-2008-00001 |
| MDR Report Key | 998747 |
| Report Source | 05 |
| Date Received | 2008-02-19 |
| Date of Report | 2008-01-29 |
| Date of Event | 2008-01-17 |
| Date Mfgr Received | 2008-01-29 |
| Device Manufacturer Date | 2007-11-01 |
| Date Added to Maude | 2008-02-21 |
| 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 | ORLANDO TADEO, JR |
| Manufacturer Street | 1717 WEST 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 ST. |
| 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 APPLIANCE |
| Generic Name | BITE-JUMPING ORTHODONTIC APPLIANCE |
| Product Code | DYJ |
| Date Received | 2008-02-19 |
| ID Number | WO#2639248 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Implant Flag | N |
| Date Removed | B |
| Device Sequence No | 1 |
| Device Event Key | 968656 |
| Manufacturer | ALLESEE ORTHODONTIC APPLIANCES |
| Manufacturer Address | 13931 SPRING ST. STURTEVANT WI 53177 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2008-02-19 |