MAUDE Adverse Event Report: CHURCH & DWIGHT CO., INC A AND H SPINBRUSH UNSPECIFIED

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-01631, 007647728a) from the united states of america was reported by a male consumer (age unspecified) who experienced chipped tooth coincident with the a and h spinbrush unspecified.The consumer's medical history and concomitant medications were not reported.On an unspecified date, the consumer initiated the a and h spinbrush unspecified via the dental route.While using it, he got his tooth chipped.No additional information was available.The action taken with a and h spinbrush unspecified and the outcome of the event chipped tooth was unknown.

• Brand Name: A AND H SPINBRUSH UNSPECIFIED
• Type of Device: A AND H SPINBRUSH UNSPECIFIED
• 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 08268
• Manufacturer Contact: jon evison ; 469 north harrison street; princeton, NJ 08543
• MDR Report Key: 15767428
• MDR Text Key: 303394720
• Report Number: 2280705-2022-01631
• 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: 10/30/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/10/2022
• 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
• Date Manufacturer Received: 10/30/2022
• 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
• Patient Outcome(s): Required Intervention
• Patient Sex: Male