FDA Adverse Event
Malfunction
Summary report: N
CVS PWTB 1G W/EF II VIP
MDR report key: 7964819
·
Received October 15, 2018
Report
- Report Number
- 1825660-2018-00433
- Event Type
- Malfunction
- Date Received
- October 15, 2018
- Date of Event
- October 2, 2018
- Report Date
- October 15, 2018
- Manufacturer
- RANIR LLC
- Product Code
- JEQ
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- VA, US
- Reporter Occupation
- OTHER
Narratives
Description of Event or Problem · 1
CONSUMER STATED THE TOOTHBRUSH NOT HAVE A LOT OF TORQUE AND THE HEAD VIBRATES ERRATICALLY. CONSUMER CLAIMED THE TOOTHBRUSH KNOCKED A FILLING LOOSE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 804578 | CVS PWTB 1G W/EF II VIP | TOOTHBRUSH, POWERED | JEQ | RANIR LLC | PWTB 1G W/EF II VIP |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |