FDA Adverse Event
Injury
Summary report: N
SMILESONIC
MDR report key: 2842000
·
Received November 14, 2012
Report
- Report Number
- 1825660-2012-00007
- Event Type
- Injury
- Date Received
- November 14, 2012
- Date of Event
- October 15, 2012
- Report Date
- November 14, 2012
- Manufacturer
- RANIR LLC
- Product Code
- JEQ
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MI, US
- Reporter Occupation
- NOT APPLICABLE
Narratives
Description of Event or Problem · 1
CONSUMER STATED THAT THE TOOTHBRUSH HEADS WERE A BAD PRODUCT AND WHILE USED RATTLED AND MADE EXCESSIVE NOISE. HE LATER NOTICED THAT THE BRUSH HEADS HAD CHIPPED HIS TOOTH. THIS REPORT IS UNCONFIRMED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | SMILESONIC | JEQ | RANIR LLC |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Disability |