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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 Problems Use of Device Problem (1670); Separation Problem (4043)
Patient Problem Tooth Fracture (2428)
Event Date 04/08/2021
Event Type  Injury  
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).
 
Event Description
The consumer stated that he was using his arm & hammer spinbrush pro clean toothbrush for the third time and the head came off the toothbrush while spinning and chipped a bottom tooth.He also stated that he lives in (b)(6).
 
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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 Key11666544
MDR Text Key245937461
Report Number2280705-2021-00014
Device Sequence Number1
Product Code JEQ
Combination Product (y/n)N
Reporter Country CodeSW
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type consumer
Reporter Occupation Other
Type of Report Initial
Report Date 04/14/2021
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
Initial Date Manufacturer Received 04/08/2021
Initial Date FDA Received04/14/2021
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 Number1
Patient Outcome(s) Disability;
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