FDA Adverse Event
Injury
Summary report: N
SPINBRUSH PROCLEAN POWERED TOOTHBRUSH
MDR report key: 2010872
·
Received March 3, 2011
Report
- Report Number
- 2280705-2011-00010
- Event Type
- Injury
- Date Received
- March 3, 2011
- Date of Event
- January 1, 2011
- Report Date
- March 2, 2011
- Manufacturer
- CHURCH & DWIGHT CO., INC.
- Product Code
- JEQ
- PMA / PMN Number
- EXEMPT
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CA, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
ADDITIONAL INFORMATION: THE PRODUCT USED WAS EITHER SPINBRUSH PRO CLEAN TOOTHBRUSH SOFT (B)(6) OR SPINBRUSH PRO CLEAN TOOTHBRUSH MEDIUM (B)(6). EXPLANATION OF SECTION: CONCLUSION: CONSUMER HAS NOT RETURNED PRODUCT TO DATE, THEREFORE, IT COULD NOT BE EVALUATED AND NO CONCLUSIONS COULD BE DRAWN.
Description of Event or Problem · 1
CONSUMER REPORTED TWO UPPER TEETH WERE CHIPPED DURING USE. DENTIST WANTS TO BOND TEETH.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | SPINBRUSH PROCLEAN POWERED TOOTHBRUSH | TOOTHBRUSH, POWERED SECTION 872.6865 (JEQ) | JEQ | CHURCH & DWIGHT CO., INC. | 66878 00078 | DD9170F1 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Disability |