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U.S. Department of Health and Human Services

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

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CHURCH & DWIGHT CO., INC. A&H SPINBRUSH PRO WHITENING SOFT; POWERED TOOTHBRUSH Back to Search Results
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.
 
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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 Key9943066
MDR Text Key189484808
Report Number2280705-2020-00010
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 04/02/2020
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 Number6687800191
Device Lot NumberDD9211D1
Was Device Available for Evaluation? Yes
Initial Date Manufacturer Received 03/19/2020
Initial Date FDA Received04/09/2020
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 Number1
Patient Outcome(s) Disability;
Patient Age59 YR
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