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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: CHURCH & DWIGHT CO., INC. A&H SPINBRUSH PRO CLEAN UNSPECIFIED; POWERED TOOTHBRUSH
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CHURCH & DWIGHT CO., INC. A&H SPINBRUSH PRO CLEAN UNSPECIFIED; POWERED TOOTHBRUSH Back to Search Results
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problem Tooth Fracture (2428)
Event Date 01/23/2022
Event Type  Injury  
Event Description
The consumer alleges that the spinbrush pro clean product broke his tooth in half.He further stated that he went to his dentist and claimed that this product is what broke his tooth.Based on this limited information, we are not aware of any of the consumer's pre-existing oral care condition(s) nor the manner in the product's history with the consumer's use.
 
Manufacturer Narrative
Product components are manufactured at the following contract manufacturing locations.Since the consumer has not returned the product to date, we are unable to determine which exact product was used and at which location the particular product was manufactured.Heads are manufactured at the following location: (b)(4).
 
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Brand Name
A&H SPINBRUSH PRO CLEAN UNSPECIFIED
Type of Device
POWERED TOOTHBRUSH
Manufacturer (Section D)
CHURCH & DWIGHT CO., INC.
500 charles ewing boulevard
ewing NJ 08628
Manufacturer Contact
stacey harshaw
469 north harrison street
princeton, NJ 08543
6098067868
MDR Report Key13424034
MDR Text Key289338481
Report Number2280705-2022-00003
Device Sequence Number1
Product Code JEQ
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Consumer
Reporter Occupation Other
Type of Report Initial
Report Date 02/02/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received02/02/2022
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
Date Manufacturer Received01/23/2022
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 Unknown
Patient Sequence Number1
Patient SexMale
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