FDA Adverse Event
Injury
Summary report: N
SPINBRUSH PRO WHITENING POWERED TOOTHBRUSH
MDR report key: 2050812
·
Received April 1, 2011
Report
- Report Number
- 2280705-2011-00016
- Event Type
- Injury
- Date Received
- April 1, 2011
- Date of Event
- February 1, 2011
- Report Date
- April 1, 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
THE CONSUMER HAS NOT RETURNED THE PRODUCT TO DATE. THE PRODUCT USED WAS EITHER SPINBRUSH PRO WHITENING POWERED TOOTHBRUSH SOFT 66878 00191 OR SPINBRUSH PRO WHITENING POWERED TOOTHBRUSH MEDIUM 66878 00193. THE PRODUCT WAS MANUFACTURED AT ONE OF THE FOLLOWING LOCATIONS. SINCE CONSUMER HAS NOT RETURNED THE PRODUCT TO DATE WE ARE UNABLE TO DETERMINE AT WHICH LOCATION THIS PARTICULAR PRODUCT WAS MADE. CONTRACT MFR: (B)(6).
Description of Event or Problem · 1
IN A PHONE CALL ON (B)(6) 2011, CONSUMER REPORTED ENAMEL CHIPS CAME OFF HIS TEETH WHILE BRUSHING AND THAT HE SOUGHT MEDICAL ATTENTION, ALTHOUGH EVIDENCE OF THIS HAS NOT BEEN RECEIVED. FOLLOW-UP ATTEMPT ON (B)(6) 2011 WAS UNSUCCESSFUL IN FINDING PHONE NUMBER AND CONSUMER DID NOT CARE TO LEAVE ONE ON (B)(6) 2011.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | SPINBRUSH PRO WHITENING POWERED TOOTHBRUSH | TOOTHBRUSH, POWERED 872.6865 (JEQ) | JEQ | CHURCH & DWIGHT CO., INC. | SEE H10 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Disability |