FDA Adverse Event Injury Summary report: N

SPINBRUSH® POWERED TOOTHBRUSH

MDR report key: 2568836 · Received May 10, 2012

Report

Report Number
2280705-2012-00056
Event Type
Injury
Date Received
May 10, 2012
Report Date
May 9, 2012
Manufacturer
CHURCH & DWIGHT CO., INC.
Product Code
JEQ
PMA / PMN Number
EXEMPT
Adverse Event
Yes
Report Source
Manufacturer report
Reporter Location
NY, US
Reporter Occupation
OTHER

Narratives

Additional Manufacturer Narrative · 1

CONSUMER REPORTS HE LAST USED THE PRODUCT THE WEEK BEFORE HE REPORTED THE INCIDENT. THE PRODUCT USED WAS EITHER SPINBRUSH PROCLEAN TOOTHBRUSH SOFT (B)(4), SPINBRUSH PROCLEAN TOOTHBRUSH. MEDIUM (B)(4), SPINBRUSH PRO WHITENING TOOTHBRUSH SOFT (B)(4) OR SPINBRUSH PRO WHITENING TOOTHBRUSH. MEDIUM (B)(4). THE CONSUMER HAS NOT RETURNED THE PRODUCT TO DATE THEREFORE WE ARE UNABLE TO DETERMINE THE EXACT PRODUCT THAT WAS USED. THE PRODUCT WAS MANUFACTURED AT ONE OF THE FOLLOWING LOCATIONS. SINCE THE CONSUMER HAS NOT RETURNED THE PRODUCT TO DATE WE ARE UNABLE TO DETERMINE AT WHICH LOCATION THIS PARTICULAR PRODUCT WAS MADE. (B)(4). 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 · 1

CONSUMER REPORTS THE TOOTHBRUSH CHIPPED HIS TOOTH.

Devices

Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
1 SPINBRUSH® POWERED TOOTHBRUSH TOOTHBRUSH, POWERED JEQ CHURCH & DWIGHT CO., INC. DD1266S2

Patients

Seq Age Sex Outcome Treatment
1 Disability