FDA Adverse Event
Malfunction
Summary report: N
SPINBRUSH POWERED TOOTHBRUSH
MDR report key: 2852359
·
Received November 13, 2012
Report
- Report Number
- 2280705-2012-00136
- Event Type
- Malfunction
- Date Received
- November 13, 2012
- Report Date
- November 12, 2012
- Manufacturer
- CHURCH & DWIGHT CO., INC.
- Product Code
- JEQ
- PMA / PMN Number
- EXEMPT
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CA, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
THE PRODUCT USED WAS EITHER SPINBRUSH PROCLEAN TOOTHBRUSH SOFT 66878 00078, SPINBRUSH PROCLEAN TOOTHBRUSH MEDIUM 66878 00079, SPINBRUSH PRO WHITENING TOOTHBRUSH SOFT 66878 00191 OR SPINBRUSH PRO WHITENING TOOTHBRUSH MEDIUM 66878 00193. (B)(4).
Description of Event or Problem · 1
CONSUMER REPORTS TOOTHBRUSH HEAD BREAKAGE DURING USE. THIS IS REPORTED AS A MALFUNCTION WITH THE POTENTIAL TO CAUSE SERIOUS INJURY. NO INJURY OCCURRED. THIS IS BEING SUBMITTED AS PART OF RETROSPECTIVE REVIEW TO IDENTIFY MALFUNCTIONS WITH THE POTENTIAL TO CAUSE SERIOUS INJURY.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | SPINBRUSH POWERED TOOTHBRUSH | TOOTHBRUSH, POWERED 872.6865 | JEQ | CHURCH & DWIGHT CO., INC. |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |