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

Model Number 6687800078

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

Patient Problem Tooth Fracture (2428)

Event Date 05/01/2022

Event Type  Injury  

Manufacturer Narrative

The consumer experience did not involve a death or represent potential serious harm to public health.The consumer did not seek medical treatment.The consumer did present as indicative of potential serious injury: ["broken tooth"].A lot code search was generated for quality review; no similar quality complaints for this product and lot code combination were reported.

Event Description

This spontaneous report (2022-cdw-00185, (b)(6)) from canada was reported by a consumer and concerns a female patient (age unspecified) who had the inside 1/2 of left, third lower tooth, broke off coincident with spinbrush pro clean fka a and h spinbrush pro clean (spinbrush pro clean soft).The patient's medical history and concomitant medications were not reported.On (b)(6) 2022, the patient initiated spinbrush pro clean fka a and h spinbrush pro clean (spinbrush pro clean soft) for the first time for brushing her teeth. at 11 a.M.Est, while brushing, she noticed that the inside back 1/2 of my lower third tooth, on my left, had broken off.She stated that she was not in pain and there was no blood.According to her, she had a little filling there and that's what held her tooth together.From the front, it looked fine, but at the back part, it was 1/2 broken off.She also stated that the tooth which broke off was not sensitive to hot or cold.The patient called her dentist and made the dentist aware of her condition, as she already had her appointment scheduled for (b)(6) 2022.No additional information was available.As per the reportability review, the consumer experience did not involve a death or represent potential serious harm to public health.The consumer did not seek medical treatment.The consumer did present the following symptoms listed in chd-sop-1330 as indicative of potential serious injury: ["broken tooth"].A lot code search was generated for quality review; no similar quality complaints for this product and lot code combination were reported.Action taken with spinbrush pro clean fka a and h spinbrush pro clean (spinbrush pro clean soft) was unknown.The outcome of the event was not recovered.

• Brand Name: SPINBRUSH PRO CLEAN FKA A AND H SPINBRUSH PRO CLEAN
• Type of Device: TOOTHBRUSH POWERED
• Manufacturer (Section D): CHURCH & DWIGHT CO., INC.; 469 north harrison street; princeton NJ 08540
• Manufacturer (Section G): CHURCH & DWIGHT CO., INC.; 500 charles ewing boulevard; ewing NJ 08628
• Manufacturer Contact: jon evison ; 469 north harrison street; princeton, NJ 08540
• MDR Report Key: 14521396
• MDR Text Key: 293351721
• Report Number: 2280705-2022-00185
• Device Sequence Number: 1
• Product Code: JEQ
• Combination Product (y/n): N
• Reporter Country Code: CA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Consumer
• Reporter Occupation: Non-Healthcare Professional
• Remedial Action: Replace
• Type of Report: Initial
• Report Date: 05/02/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Model Number: 6687800078
• Device Lot Number: DD00955S1
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 05/02/2022
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 05/27/2022
• 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): Other
• Patient Sex: Female