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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: CHURCH & DWIGHT CO., INC. ARM & HAMMER SPINBRUSH UNSPECIFIED; POWERED TOOTHBRUSH

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CHURCH & DWIGHT CO., INC. ARM & HAMMER SPINBRUSH UNSPECIFIED; POWERED TOOTHBRUSH Back to Search Results
Device Problems Loss of Power (1475); Battery Problem: Low Impedance (2973)
Patient Problem Tooth Fracture (2428)
Event Date 03/24/2020
Event Type  Injury  
Manufacturer Narrative
Product components are manufactured at the following contract manufacturing locations.Since the consumer won't be able to return the product, 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 alleges that while she was using her spinbrush, the battery died and it caused her to break a tooth because it stopped so fast and hit her tooth.She did not seek medical attention.
 
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Brand Name
ARM & HAMMER SPINBRUSH UNSPECIFIED
Type of Device
POWERED TOOTHBRUSH
Manufacturer (Section D)
CHURCH & DWIGHT CO., INC.
500 charles ewing boulevard
ewing, nj
Manufacturer Contact
stacey harshaw
469 north harrison street
princeton, nj 
8067868
MDR Report Key9943065
MDR Text Key189484723
Report Number2280705-2020-00009
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 04/01/2020
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
Was Device Available for Evaluation? No
Initial Date Manufacturer Received 03/25/2020
Initial Date FDA Received04/09/2020
Was Device Evaluated by Manufacturer? No
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
Patient Outcome(s) Disability;
Patient Age52 YR
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