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

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-01275, 007598719a) from the united states of america was reported by a female consumer (age unspecified) who experienced a chipped tooth coincident with a and h spinbrush pro whitening (a and h spinbrush pro whitening medium).The consumer's medical history and concomitant medications were not reported.On an unspecified date, the consumer initiated a and h spinbrush pro whitening (a and h spinbrush pro whitening medium) via the dental route.At the first time of use, it chipped a tooth.She stated that the product was terrible and extremely hard on her teeth.No additional information was available.The action taken with a and h spinbrush pro whitening (a and h spinbrush pro whitening medium) and the outcome of the event was unknown.

• Brand Name: A AND H SPINBRUSH PRO WHITENING MEDIUM
• Type of Device: TOOTHBRUSH, POWERED
• 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 08628
• Manufacturer Contact: jon evison ; 469 north harrison street; princeton 08543
• MDR Report Key: 15299836
• MDR Text Key: 298667567
• Report Number: 2280705-2022-01275
• 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: 08/12/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/26/2022
• 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?: Device Not Returned to Manufacturer
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Outcome(s): Disability
• Patient Sex: Female