D
Patient 1
A DOCTOR'S OFFICE ALLEGED THAT EIGHT (8) PATIENTS HAD EXPERIENCED MUCOSA DAMAGE AFTER WEARING THE INSPIRE ICE BRACKET. THIS IS THE SEVENTH OF EIGHT (8) REPORTS.
MAUDE MDR 4600780
- MDR report key
- 4600780
- Report number
- 2016150-2015-00010
- Event key
- 0
- Event type
- 3
- Date received
- 2015-03-13
- Adverse event
- 3
- Product problem
- 3
- Patients in event
- 0
- Reporter occupation
- 116
- Health professional
- 3
- Initial report to FDA
- 3
- Event location
- 0
Manufacturer Contact#
- Contact
- MRS. KERRI CASINO
- 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 | INSPIRE ICE | ORTHODONTIC BRACKET | ORMCO CORPORATION | EJF | 746-4300 | R | N |
Patients#
| Sequence | Received | Treatment | Outcome |
|---|---|---|---|
| 1 | 2015-03-13 | 0 | 1. O; 2. R |
Event Narratives#
N
Patient 1
SPECIFIC PATIENT INFORMATION WITH REGARD TO GENDER, AGE AND WEIGHT WAS NOT PROVIDED. THE PATIENT WAS PRESCRIBED PAIN MEDICATION AND MEDICATION FOR THE MUCOSA. TO DATE, THE PATIENT HAS FULLY RECOVERED AND IS DOING FINE. THE DEVICE INVOLVED IN THE ALLEGED INCIDENT WAS NOT RETURNED AND NO LOT NUMBER WAS PROVIDED; THEREFORE, NO EVALUATION CAN BE CONDUCTED.