MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05 report with the FDA on 2012-03-15 for HERBST manufactured by Allesee Orthodontic Appliances.
[20229181]
The customer stated that upper portion of the herbst is causing sores.
Patient Sequence No: 1, Text Type: D, B5
[20537180]
The patient was prescribed chlorhexidine, an antiseptic rinse, for treatment. The doctor's office stated that the new appliance will not be placed at the moment. The patient's parents will decide whether the appliance should be placed or not, after meeting with the doctor. To date, the patient is doing fine. The appliance was not returned, therefore, no evaluation of the appliance could be conducted.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2184045-2012-00004 |
| MDR Report Key | 2493333 |
| Report Source | 05 |
| Date Received | 2012-03-15 |
| Date of Report | 2012-02-14 |
| Date Mfgr Received | 2012-02-14 |
| Device Manufacturer Date | 2011-09-30 |
| Date Added to Maude | 2012-03-16 |
| 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 | MR. ORLANDO TADEO, JR. |
| Manufacturer Street | 1717 W 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 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 | 2012-03-15 |
| ID Number | WORK ORDER #3439124 |
| 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 | 2012-03-15 |