MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 04 report with the FDA on 2007-10-24 for HERBST APPLIANCE manufactured by Allesee Orthodontic Appliances.
[21956367]
In 2007, a pt's parent alleged that half of the pt's tooth broke off when the orthodontist removed the herbst appliance during orthodontic treatment.
Patient Sequence No: 1, Text Type: D, B5
[22049043]
This alleged incident and the use of the herbst appliance could not be confirmed. The complainant (the alleged pt's mother) would not disclose the name of the treating orthodontist to confirm the use of the herbst appliance. Additionally, the pt could not be located in allesee orthodontic appliance's pt database.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2184045-2007-00003 |
| MDR Report Key | 931657 |
| Report Source | 04 |
| Date Received | 2007-10-24 |
| Date of Report | 2007-09-26 |
| Date Mfgr Received | 2007-09-26 |
| Date Added to Maude | 2007-10-29 |
| 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 | 0 |
| Initial Report to FDA | 0 |
| 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 | 2007-10-24 |
| 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 | 905583 |
| Manufacturer | ALLESEE ORTHODONTIC APPLIANCES |
| Manufacturer Address | 13931 SPRING ST. STURTEVANT WI 53177 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2007-10-24 |