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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: CHURCH & DWIGHT CO., INC. A&H SPINBRUSH PRO+ DEEP CLEAN 2 CT; POWERED TOOTHBRUSH HEAD
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CHURCH & DWIGHT CO., INC. A&H SPINBRUSH PRO+ DEEP CLEAN 2 CT; POWERED TOOTHBRUSH HEAD Back to Search Results
Model Number 6687800403
Device Problem Break (1069)
Patient Problem Injury (2348)
Event Type  malfunction  
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 alleges that while his wife was brushing her teeth the brush head broke into pieces and cut her inner lip.He further states that the plastic wasn't sturdy and it cracked along the neck of the toothbrush head.The plastic fell off, but the heads were still attached.At this time, his wife is fully healed.
 
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Brand Name
A&H SPINBRUSH PRO+ DEEP CLEAN 2 CT
Type of Device
POWERED TOOTHBRUSH HEAD
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 Key10003597
MDR Text Key218018952
Report Number2280705-2020-00013
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 04/27/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received04/27/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Lay User/Patient
Device Model Number6687800403
Was Device Available for Evaluation? No
Date Manufacturer Received03/30/2020
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 Reuse
Patient Sequence Number1
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