FDA Adverse Event
Injury
Summary report: N
SPINBRUSH¿ PROCLEAN¿ POWERED TOOTHBRUSH
MDR report key: 2914038
·
Received January 14, 2013
Report
- Report Number
- 2280705-2013-00004
- Event Type
- Injury
- Date Received
- January 14, 2013
- Date of Event
- March 16, 2012
- Report Date
- January 14, 2013
- Manufacturer
- CHURCH & DWIGHT CO., INC.
- Product Code
- JEQ
- PMA / PMN Number
- EXEMPT
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- IL, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
THE PRODUCT USED WAS EITHER SPINBRUSH PROCLEAN POWERED TOOTHBRUSH SOFT (B)(4) OR SPINBRUSH PROCLEAN POWERED TOOTHBRUSH MEDIUM (B)(4).
Description of Event or Problem · 1
CONSUMER REPORTS TOOTHBRUSH HEAD BREAKAGE DURING USE RESULTING IN A CHIPPED TOOTH.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 21078 | SPINBRUSH¿ PROCLEAN¿ POWERED TOOTHBRUSH | TOOTHBRUSH, POWERED | JEQ | CHURCH & DWIGHT CO., INC. |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Disability |