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