MAUDE Adverse Event Report: CHURCH & DWIGHT CO., INC. A&H SPINBRUSH PRO WHITENING SOFT; POWERED TOOTHBRUSH

Model Number 6687800191

Device Problem Insufficient Information (3190)

Patient Problems Sensitivity of Teeth (2427); No Code Available (3191)

Event Date 01/02/2021

Event Type  Injury  

Manufacturer Narrative

Additional information for mfr information: 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 alleges that his fingernails broke on the switch of the spinbrush toothbrush.Additionally, it was also alleged that the bristles on the spinbrush caused damage to a crown that the consumer paid (b)(6) for.The consumer stated that he had to get another crown for (b)(6).

• Brand Name: A&H SPINBRUSH PRO WHITENING SOFT
• Type of Device: POWERED TOOTHBRUSH
• Manufacturer (Section D): CHURCH & DWIGHT CO., INC.; 500 charles ewing boulevard; ewing NJ 08628
• Manufacturer Contact: stacey harshaw ; 469 north harrison street; princeton, NJ 08543 ; 6098067868
• MDR Report Key: 11204748
• MDR Text Key: 227933777
• Report Number: 2280705-2021-00002
• Device Sequence Number: 1
• Product Code: JEQ
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer
• Type of Report: Initial
• Report Date: 01/20/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/20/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Model Number: 6687800191
• Date Manufacturer Received: 01/06/2021
• 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: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention; Disability