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

Lot Number DD1153?1

Device Problem Patient Device Interaction Problem (4001)

Patient Problem Tooth Fracture (2428)

Event Type  Injury  

Event Description

This spontaneous report ((b)(6)) from the united states of america was reported by a consumer (parent) and concerns a 19-year-old male who experienced severe cracks in his front teeth coincident with spinbrush pro clean fka a and h spinbrush pro clean (spinbrush pro clean medium).The patient's medical history and concomitant medications were not reported.On an unspecified date, around in (b)(6) 2022, the patient initiated spinbrush pro clean fka a and h spinbrush pro clean (spinbrush pro clean medium) (lot number: dd1153?1), used twice a day at least to brush teeth.Around a month later, in the week of this report, he noticed cracks in the middle of his two front teeth.On (b)(6) 2022, he stopped using the spinbrush.At the time of this report, the reporter mentioned that the crack was still happening and was getting worse.He did not receive any medical attention or treatment.No additional information was available.The action taken with spinbrush pro clean fka a and h spinbrush pro clean (spinbrush pro clean medium) was discontinued.The outcome of the event was not recovered.

• Brand Name: SPINBRUSH PRO CLEAN 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: 15075951
• MDR Text Key: 296369468
• Report Number: 2280705-2022-00833
• Device Sequence Number: 1
• Product Code: EFW
• 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: 07/11/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/21/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Lot Number: DD1153?1
• Was Device Available for Evaluation?: No
• 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): Other
• Patient Age: 19 YR
• Patient Sex: Male