FDA Adverse Event
Malfunction
Summary report: N
ARM & HAMMER SPINBRUSH KIDS UNSPECIFIED
MDR report key: 10117274
·
Received June 3, 2020
Report
- Report Number
- 2280705-2020-00017
- Event Type
- Malfunction
- Date Received
- June 3, 2020
- Date of Event
- May 18, 2020
- Report Date
- June 3, 2020
- Manufacturer
- CHURCH & DWIGHT CO., INC.
- Product Code
- JEQ
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
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. PRODUCT COMPONENTS ARE MANUFACTURED AT THE FOLLOWING CONTRACT MANUFACTURING LOCATIONS. SINCE THE CONSUMER IS NOT ABLE TO RETURN THE PRODUCT, WE ARE UNABLE TO DETERMINE WHICH EXACT PRODUCT WAS USED AND AT WHICH LOCATION THE PARTICULAR PRODUCT WAS MANUFACTURED. HEADS ARE MANUFACTURED AT THE FOLLOWING LOCATION: (B)(4).
Description of Event or Problem · 1
THE CONSUMER STATES THAT SHE BOUGHT HER THREE YEAR OLD DAUGHTER A SPINBRUSH AND THE TOP SNAPPED OFF.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 581147 | ARM & HAMMER SPINBRUSH KIDS UNSPECIFIED | POWERED TOOTHBRUSH | JEQ | CHURCH & DWIGHT CO., INC. |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 3 YR |