FDA Adverse Event
Malfunction
Summary report: N
EQUATE
MDR report key: 6303667
·
Received February 6, 2017
Report
- Report Number
- 1825660-2017-00050
- Event Type
- Malfunction
- Date Received
- February 6, 2017
- Date of Event
- January 9, 2017
- Report Date
- January 9, 2017
- Manufacturer
- RANIR LLC
- Product Code
- JEQ
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- AZ, US
- Reporter Occupation
- DEVICE UNATTENDED
Narratives
Description of Event or Problem · 1
REPORTER/PATIENT CLAIM THE BRISTLES WERE HARD AND FALLING OFF THE EQ SMILE SONIC PRO 3PK.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 88599 | EQUATE | TOOTHBRUSH, POWERED | JEQ | RANIR LLC | EQ SMILE SONIC PRO 3PK | 162837 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |