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

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Tooth Fracture (2428)

Event Type  Injury  

Event Description

This spontaneous report (2022-cdw-01458 (b)(6)) from the united states of america was reported by a male consumer (age unspecified) who had two broken teeth, which were very painful coincident with the spinbrush pro clean replacement head medium.The consumer's medical history and concomitant medications were not reported.On an unspecified date, the consumer initiated the spinbrush pro clean replacement head medium.At the initial use, he had 2 broken teeth, which was very painful.He stated he had very noticeable and embarrassing broken smile and not able to eat a variety of things like cold, hot, crunchy or sweet.He confirmed that due to his broken teeth, he had a dramatic change in daily routine and social life.No additional information was available.The action taken with spinbrush pro clean replacement head medium and the outcome of the events were unknown.

• Brand Name: SPINBRUSH PRO CLEAN REPLACEMENT HEAD MEDIUM
• Type of Device: SPINBRUSH PRO CLEAN MEDIUM
• Manufacturer (Section D): CHURCH & DWIGHT CO., INC; 469 north harrison street; princeton NJ 08543
• Manufacturer (Section G): CHURCH & DWIGHT CO., INC; 500 charles ewing boulevard; ewing NJ 08628
• Manufacturer Contact: jon evison ; 469 north harrison street; princeton, NJ 08543
• MDR Report Key: 15526485
• MDR Text Key: 301030335
• Report Number: 2280705-2022-01458
• 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: 09/20/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/03/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Was Device Available for Evaluation?: No
• Was Device Evaluated by Manufacturer?: No
• 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
• Patient Outcome(s): Required Intervention
• Patient Sex: Male