FDA Adverse Event
Summary report: N
ORBIT BRILLIANT WHITE
MDR report key: 6186914
·
Received December 19, 2016
Report
- Report Number
- 1825660-2016-00053
- Date Received
- December 19, 2016
- Date of Event
- October 3, 2016
- Report Date
- November 17, 2016
- Manufacturer
- RANIR LLC
- Product Code
- EFW
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Occupation
- DEVICE UNATTENDED
Narratives
Description of Event or Problem · 1
THEY ARE FALLING APART WHEN HE IS BRUSHING HIS TEETH.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 838624 | ORBIT BRILLIANT WHITE | TOOTHBRUSH, MANUAL | EFW | RANIR LLC | MNTB ORB BRIL WH OPT SO 2PK |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |