FDA Adverse Event
Malfunction
Summary report: N
EQUATE MNTB ORB BRIL WH OPT SO 2PK
MDR report key: 7475353
·
Received May 1, 2018
Report
- Report Number
- 1825660-2017-00306
- Event Type
- Malfunction
- Date Received
- May 1, 2018
- Date of Event
- April 4, 2018
- Report Date
- May 1, 2018
- Manufacturer
- RANIR LLC
- Product Code
- EFW
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NJ, US
- Reporter Occupation
- PATIENT
Narratives
Description of Event or Problem · 1
CUSTOMER STATED THAT THE EQ ORBIT BRILLIANT WHITE OPTIMUM SOFT 2 PK RUBBER PIECE FELL OUT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 318190 | EQUATE MNTB ORB BRIL WH OPT SO 2PK | TOOTHBRUSH, MANUAL | EFW | RANIR LLC | MNTB ORB BRIL WH OPT SO 2PK | 8357 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |