MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional report with the FDA on 2018-12-03 for CARRIERE MOTION 3D COLORS CLASS II 27MM RIGHT - SILVER 424-927RN manufactured by Ortho Organizers, Inc.
[129042539]
Dentist prescribed debactrol for "canker sores" on (b)(6). It is expected that the prescribed medication will resolve the irritation.
Patient Sequence No: 1, Text Type: N, H10
[129042540]
Patient had device bonded on (b)(6) 2018. On (b)(6), patient presented to dental office with canker sores. Device was debonded, and debacterol treatment was initiated by dentist on (b)(6) 2018.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2081322-2018-00002 |
| MDR Report Key | 8124525 |
| Report Source | HEALTH PROFESSIONAL |
| Date Received | 2018-12-03 |
| Date of Report | 2018-11-19 |
| Date of Event | 2018-11-07 |
| Date Mfgr Received | 2018-11-19 |
| Date Added to Maude | 2018-12-03 |
| 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 |
| Reporter Occupation | DENTIST |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | MARY PEARMAN |
| Manufacturer Street | 1822 ASTON AVENUE |
| Manufacturer City | CARLSBAD CA 92008 |
| Manufacturer Country | US |
| Manufacturer Postal | 92008 |
| Manufacturer G1 | ORTHO ORGANIZERS, INC |
| Manufacturer Street | 1822 ASTON AVENUE |
| Manufacturer City | CARLSBAD CA 920087306 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 920087306 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | CARRIERE MOTION 3D COLORS CLASS II 27MM RIGHT - SILVER |
| Generic Name | METAL ORTHODONTIC BRACKET |
| Product Code | EJF |
| Date Received | 2018-12-03 |
| Model Number | 424-927RN |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | ORTHO ORGANIZERS, INC |
| Manufacturer Address | 1822 ASTON AVENUE CARLSBAD CA 920087306 US 920087306 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2018-12-03 |