MAUDE Adverse Event Report: CHURCH & DWIGHT CO., INC. ARM & HAMMER SPINBRUSH PRO CLEAN MEDIUM; POWERED TOOTHBRUSH

Model Number 6687800079

Device Problem Break (1069)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 07/30/2020

Event Type  malfunction  

Manufacturer Narrative

Product components are manufactured at the following contract manufacturing locations.Since the consumer has not returned the product to date, 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).

Event Description

The consumer stated that after a month of her daughter using the spinbrush, the top part broke off in tiny pieces of plastic while she was using it.

• Brand Name: ARM & HAMMER SPINBRUSH PRO CLEAN MEDIUM
• Type of Device: POWERED TOOTHBRUSH
• Manufacturer (Section D): CHURCH & DWIGHT CO., INC.; 500 charles ewing boulevard; ewing, nj
• Manufacturer Contact: stacey harshaw ; 469 north harrison street; princeton, nj ; 8067868
• MDR Report Key: 10408426
• MDR Text Key: 204217230
• Report Number: 2280705-2020-00024
• Device Sequence Number: 1
• Product Code: JEQ
• Combination Product (y/n): N
• Reporter Country Code: CA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 08/14/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: 6687800079
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 08/03/2020
• Initial Date FDA Received: 08/14/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1