MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05 report with the FDA on 2014-10-22 for HERBST manufactured by Allesee Orthodontic Appliances.
[4982980]
A doctor alleged that a patient had experienced an infection of the gingival tissue while wearing a herbst appliance.
Patient Sequence No: 1, Text Type: D, B5
[12211729]
Specific patient information such as gender, age, and weight was not provided. The doctor reported that the patient presented with poor oral hygiene and food debris had lodged into the tissue at the point of the herbst crown attachment, creating the infection. The doctor removed the crown from the appliance and prescribed a chlorhexidine rinse for treatment. To date, the patient is doing fine. A new crown will be fabricated.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2184045-2014-00006 |
| MDR Report Key | 4193760 |
| Report Source | 05 |
| Date Received | 2014-10-22 |
| Date of Report | 2014-10-09 |
| Date Mfgr Received | 2014-10-09 |
| Device Manufacturer Date | 2014-04-14 |
| Date Added to Maude | 2014-10-22 |
| 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 WEST COLLINS AVENUE |
| 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 | 2014-10-22 |
| ID Number | WO #7657743 |
| 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 | 2014-10-22 |