FDA Adverse Event
Malfunction
Summary report: N
SONIC PRO
MDR report key: 5059299
·
Received September 5, 2015
Report
- Report Number
- 1825660-2015-00083
- Event Type
- Malfunction
- Date Received
- September 5, 2015
- Date of Event
- August 6, 2015
- Report Date
- September 3, 2015
- Manufacturer
- RANIR LLC
- Product Code
- JEQ
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MI, US
- Reporter Occupation
- DEVICE UNATTENDED
Narratives
Description of Event or Problem · 1
TOOTHBRUSH BRISTLES BECAME STUCK IN CONSUMER'S TEETH AND BRISTLES WERE RELEASED FROM THE BRUSH HEAD.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 590371 | SONIC PRO | ELECTRIC TOOTHBRUSH REPLACEMENT HEAD | JEQ | RANIR LLC |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |