FDA Adverse Event
Injury
Summary report: N
SPINBRUSH PRO WHITENING UNKNOWN
MDR report key: 9147799
·
Received October 2, 2019
Report
- Report Number
- 2280705-2019-00029
- Event Type
- Injury
- Date Received
- October 2, 2019
- Date of Event
- September 4, 2019
- Report Date
- October 23, 2019
- Manufacturer
- CHURCH & DWIGHT CO., INC.
- Product Code
- JEQ
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NE, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 0
THIS REPORT AND THE INFORMATION SUBMITTED UNDER THIS REPORT DO NOT CONSTITUTE AN ADMISSION THAT THE DEVICE OR CHURCH & DWIGHT CO., INC. OR ANY OF ITS EMPLOYEES CAUSED OR CONTRIBUTED TO THE EVENT DESCRIBED HEREIN OR THAT THE EVENT AS REPORTED TO CHURCH & DWIGHT ACTUALLY OCCURRED.
Description of Event or Problem · 0
PRODUCT RECEIVED AND EVALUATED. THE EVALUATION DOES NOT CHANGE INITIAL REPORTABILITY REQUIREMENTS.
Description of Event or Problem · 1
THE CONSUMER STATED THAT WHILE BRUSHING HER TEETH, THE TOOTHBRUSH ALLEGEDLY CHIPPED HER TOP FRONT LEFT TOOTH OFF AT THE CORNER. THE CONSUMER IS SEEKING MEDICAL ATTENTION FROM A DENTIST.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 942440 | SPINBRUSH PRO WHITENING UNKNOWN | POWERED TOOTHBRUSH | JEQ | CHURCH & DWIGHT CO., INC. | DD8307A1 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 30 YR |