MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05 report with the FDA on 2007-10-24 for HERBST APPLIANCE manufactured by Allesee Orthodontic Appliances.
[734686]
The doctor informed allesee orthodontic appliances that the pt may be showing signs of a reaction to the herbst appliance. The pt has been salivating heavily since the placement of the appliance.
Patient Sequence No: 1, Text Type: D, B5
[7883613]
The appliance may have aggravated the pt's existing salivating disorder causing irritation due to the excess saliva. The doctor prescribed a topical ointment for the irritation in 2007. The medication resolved the irritation. The pt is now doing fine and continues to use the device.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2184045-2007-00004 |
| MDR Report Key | 931656 |
| Report Source | 05 |
| Date Received | 2007-10-24 |
| Date of Report | 2007-10-01 |
| Date of Event | 2007-10-01 |
| Date Mfgr Received | 2007-10-01 |
| Device Manufacturer Date | 2007-05-01 |
| 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 | 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 | 2007-10-24 |
| ID Number | WO#2544805/05-2007 |
| 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 | 905594 |
| Manufacturer | ALLESEE ORTHODONTIC APPLIANCES |
| Manufacturer Address | 13931 SPRING ST. STURTEVANT WI 53177 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2007-10-24 |