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

Device Problem Material Fragmentation (1261)

Patient Problems Hypoesthesia (2352); Tooth Fracture (2428)

Event Type  Injury  

Event Description

This spontaneous report (b)(4) from the united states of america was reported by a male consumer (age between 18 to 30 years).On an unspecified date, the consumer used an a and h spinbrush pro clean (unspecified) to brush their teeth; while using the product the head of the toothbrush "thing" popped off the base in consumer's mouth chipping a tooth; his tooth felt numb and "weird".They sought medical treatment at the urgent care but consumer did not elaborate on treatment received; his condition remained unchanged at the time of report.No additional information was available.The consumer's medical history and concomitant medications were not reported.A retrieval kit for product was sent to consumer for inspection by quality; however product was not received.

• Brand Name: A AND H SPINBRUSH PRO CLEAN UNSPECIFIED
• Type of Device: A AND H SPINBRUSH PRO CLEAN 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 08628
• Manufacturer Contact: jon evison ; 469 north harrison street; princeton, NJ 08543
• MDR Report Key: 15428326
• MDR Text Key: 299962211
• Report Number: 2280705-2022-01403
• 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: 08/02/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/15/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• 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): Required Intervention
• Patient Sex: Male