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

Model Number 6687800079

Device Problems Break (1069); Material Twisted/Bent (2981)

Patient Problem Insufficient Information (4580)

Event Date 03/12/2021

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 alleges that while using the spinbrush the head of the toothbrush snapped into his mouth which has bent a part of his permanent retainer on his bottom jaw.This is being reported conservatively based on the allegation of a malfunction (small part breakage) with the potential to cause serious injury (choking).

• Brand Name: SPINBRUSH PRO CLEAN MEDIUM
• 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: 11603497
• MDR Text Key: 244860618
• Report Number: 2280705-2021-00010
• Device Sequence Number: 1
• Product Code: JEQ
• Combination Product (y/n): N
• Reporter Country Code: US
• 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: 04/01/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/01/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: 6687800079
• Date Manufacturer Received: 03/12/2021
• 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