D
Patient 1
A DOCTOR ALLEGED THAT A PATIENT DEVELOPED A SORE IN HIS MOUTH WHILE WEARING THE HERBST APPLIANCE ON TWO (2) SEPARATE OCCASIONS.
MAUDE MDR 2886442
- MDR report key
- 2886442
- Report number
- 2184045-2012-00013
- Event key
- 0
- Event type
- 3
- Date received
- 2012-12-26
- 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
- MRS. WENDY GARMAN
- Address
- 1717 WEST COLLINS AVENUE 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 | HERBST | BITE-JUMPING ORTHODONTIC APPLIANCE | ALLESEE ORTHODONTIC APPLIANCES | EJF | R | N |
Patients#
| Sequence | Received | Treatment | Outcome |
|---|---|---|---|
| 1 | 2012-12-26 | 0 | 1. O; 2. R |
Event Narratives#
N
Patient 1
THE DOCTOR HAD REMOVED THE APPLIANCE AFTER THE FIRST OCCURRENCE OF THE SORE; HOWEVER, THE APPLIANCE WAS PLACED AGAIN ONCE THE PATIENT HAD HEALED. AFTER THE SECOND OCCURRENCE OF THE SORE, THE APPLIANCE WAS REMOVED AND THE PATIENT WAS PRESCRIBED A CHLORHEXIDINE ORAL RINSE FOR TREATMENT. TO DATE, THE PATIENT IS DOING FINE AND HAS FULLY RECOVERED. A NEW APPLIANCE WILL BE FABRICATED WITH CONSIDERATION TO PATIENT COMFORT.