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

Model Number 6687800191

Device Problems Use of Device Problem (1670); Vibration (1674)

Patient Problem Tooth Fracture (2428)

Event Date 03/18/2020

Event Type  Injury  

Event Description

The consumer alleges that the vibration from the spinbrush knocked a filling from his upper left back tooth.He spit out a silver piece into the sink drain.He also states that the filling was an old filling.He plans to call his dentist.

• Brand Name: A&H SPINBRUSH PRO WHITENING SOFT
• Type of Device: POWERED TOOTHBRUSH
• Manufacturer (Section D): CHURCH & DWIGHT CO., INC.; 500 charles ewing boulevard; ewing, nj
• Manufacturer (Section G): HAYCO LTD.; 4f citicorp centre; 18 whitfield road; causeway bay, hong kong ; CH
• Manufacturer Contact: stacey harshaw ; 469 north harrison street; princeton, nj ; 8067868
• MDR Report Key: 9943066
• MDR Text Key: 189484808
• Report Number: 2280705-2020-00010
• 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: 04/02/2020

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 Operator: Lay User/Patient
• Device Model Number: 6687800191
• Device Lot Number: DD9211D1
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: 03/19/2020
• Initial Date FDA Received: 04/09/2020
• 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: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Disability
• Patient Age: 59 YR