MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05 report with the FDA on 2009-09-17 for HERBST APPLIANCE manufactured by Allesee Orthodontic Appliances.
[1233022]
In 2009, a doctor alleged that a herbst appliance dug into a patient's cheek and caused an infection.
Patient Sequence No: 1, Text Type: D, B5
[8411816]
The doctor's office was called, and it was confirmed that a screw on the herbst appliance dug into the patient's cheek, causing swelling and infection of the patient's cheek. The patient was given a hydrogen peroxide antiseptic rinse and antibiotics were prescribed to treat the infection. The herbst appliance was sent back, and will be repaired. The patient will be fitted with the repaired appliance. The patient is doing fine. This incident is reportable because medical intervention was necessary to preclude a serious injury.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2184045-2009-00002 |
| MDR Report Key | 1475077 |
| Report Source | 05 |
| Date Received | 2009-09-17 |
| Date of Report | 2009-08-21 |
| Date Mfgr Received | 2009-08-21 |
| Device Manufacturer Date | 2009-07-08 |
| Date Added to Maude | 2009-09-18 |
| 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 APPLIANCE |
| Generic Name | BITE-JUMPING ORTHODONTIC APPLIANCE |
| Product Code | DYJ |
| Date Received | 2009-09-17 |
| ID Number | WO 2978147/3003474 |
| Operator | OTHER |
| Device Availability | Y |
| Device Eval'ed by Mfgr | Y |
| 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. Required No Informationntervention | 2009-09-17 |