D
Patient 1
A DOCTOR REPORTED THAT THE ADVANSYNC APPLIANCE WAS CAUSING THE INSIDE OF A PATIENT'S LEFT CHEEK TO BE CUT UP.
MAUDE MDR 2424282
- MDR report key
- 2424282
- Report number
- 2016150-2012-00006
- Event key
- 0
- Event type
- 3
- Date received
- 2012-01-20
- Adverse event
- 3
- Product problem
- 3
- Patients in event
- 0
- Reporter occupation
- 0
- Health professional
- 3
- Initial report to FDA
- 3
- Event location
- 0
Manufacturer Contact#
- Contact
- MR. ORLANDO TADEO, JR.
- Address
- 1717 W. COLLINS AVE. ORANGE CA 92867 US
- Phone
- 714-714-7145
- Report source
- M
- Manufacturer link flag
- Y
Devices#
| Seq | Brand | Generic | Manufacturer | Product code | Model | Catalog | Lot | PMA | 510(k) | Implant | Evaluated | Availability |
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 1 | ADVANSYNC | BITE-JUMPING ORTHODONTIC APPLIANCE | ORMCO CORPORATION | EJF | Y | Y |
Patients#
| Sequence | Received | Treatment | Outcome |
|---|---|---|---|
| 1 | 2012-01-20 | 0 | 1. O |
Event Narratives#
N
Patient 1
THE PATIENT WAS PRESCRIBED AN ANTIBIOTIC (AMOXICILLIN) FOR TREATMENT OF THE PATIENT'S CHEEK. TO DATE, THE PATIENT IS DOING FINE AND HAS FULLY RECOVERED. MODIFICATIONS TO THE EXISTING APPLIANCE WILL BE MADE WITH REGARD TO PATIENT COMFORT.