FDA Adverse Event
Malfunction
Summary report: N
XTREME WHITE TOOTHBRUSH
MDR report key: 4890250
·
Received July 4, 2015
Report
- Report Number
- 1825660-2015-00071
- Event Type
- Malfunction
- Date Received
- July 4, 2015
- Date of Event
- June 2, 2015
- Report Date
- July 1, 2015
- Manufacturer
- RANIR LLC
- Product Code
- EFW
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Occupation
- DEVICE UNATTENDED
Narratives
Additional Manufacturer Narrative · 1
DEVICE NOT RETURNED.
Description of Event or Problem · 1
BRISTLES FELL OUT OF TOOTHBRUSH.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 434127 | XTREME WHITE TOOTHBRUSH | MANUAL TOOTHBRUSH | EFW | RANIR LLC |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |