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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 Problem Patient-Device Incompatibility (2682)
Patient Problems Pain (1994); Tooth Fracture (2428)
Event Date 03/04/2021
Event Type  Injury  
Event Description
The consumer alleges that this toothbrush chipped the back tooth on the bottom left side.She noticed the chipped tooth two hours after using the toothbrush.She also reported pain with the chipped tooth.The consumer did not seek medical attention.
 
Manufacturer Narrative
This report and the information submitted under this report do not constitute an admission that the device or church & dwight co., inc.Or any of its employees caused or contributed to the event described herein or that the event as reported to church & dwight actually occurred.This follow-up report is being submitted because we received additional information regarding the specific product name and upc number.
 
Event Description
The consumer alleges that this toothbrush chipped the back tooth on the bottom left side.She noticed the chipped tooth two hours after using the toothbrush.She also reported pain with the chipped tooth.The consumer did not seek medical attention.
 
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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 08628
MDR Report Key11517148
MDR Text Key240728397
Report Number2280705-2021-00008
Device Sequence Number1
Product Code JEQ
Combination Product (y/n)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type consumer
Type of Report Initial,Followup
Report Date 04/06/2021
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
Device Model Number6687800191
Device Lot NumberDD0177D2
Was Device Available for Evaluation? Yes
Initial Date Manufacturer Received 03/04/2021
Initial Date FDA Received03/18/2021
Supplement Dates Manufacturer Received03/04/2021
Supplement Dates FDA Received04/06/2021
Patient Sequence Number1
Patient Outcome(s) Disability;
Patient Age23 YR
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