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

Model Number 687800078

Device Problems Adverse Event Without Identified Device or Use Problem (2993); Patient Device Interaction Problem (4001)

Patient Problems Pain (1994); Tooth Fracture (2428)

Event Type  Injury  

Event Description

This spontaneous report ((b)(4)) from the united states of america was reported by a female consumer (age in her 50s) who developed damaged teeth coincident with using spinbrush pro clean soft.The consumer's medical history and the concomitant medications were not reported.On an unspecified date, the consumer initiated spinbrush pro clean soft via the dental route.She alleged that the spinbrush had caused damage to her teeth.She had to get a crown on one of her teeth.No additional information was available.The action taken with spinbrush pro clean soft, and the outcome of the event were unknown.

Event Description

This spontaneous report (b)(4) from the united states of america was reported by a 59-year-old female consumer who experienced toothache and damaged teeth while using spinbrush pro clean soft.On an unspecified date in 2022, the consumer initiated spinbrush pro clean soft via the dental route for cleaning.After 6 months, she started experiencing toothache.She alleged that it damaged her teeth.She visited her dentist who stated that she needs to crown her teeth.She had crown on one of her teeth.She stopped using the spinbrush.However, her condition did not improve.No additional information was available.The action taken with spinbrush pro clean soft was withdrawn.The outcome of the events was not recovered.Follow up information was received on 12-jul-2023: reporter details, product details (new lot number), new event (toothache) and date of occurrence added.The patient detail(age), action taken, outcome of the events and treatment description updated.New information received was assessed, and it does not change the reportability of the case.

• Brand Name: SPINBRUSH PRO CLEAN SOFT
• 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 NJ 08628
• Manufacturer Contact: jon evison ; 469 north harrison street; princeton, NJ 08543
• MDR Report Key: 16425389
• MDR Text Key: 310045732
• Report Number: 2280705-2023-00369
• 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,Followup
• Report Date: 08/08/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/23/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Model Number: 687800078
• Device Lot Number: DD0144D2, DD2055B
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Was Device Evaluated by Manufacturer?: Yes
• 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 Age: 59 YR
• Patient Sex: Female