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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: AUTOBRUSH AUTOBRUSH; TOOTHBRUSH, POWERED
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AUTOBRUSH AUTOBRUSH; TOOTHBRUSH, POWERED Back to Search Results
Model Number 2020
Device Problems Device Slipped (1584); Therapeutic or Diagnostic Output Failure (3023)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 08/17/2020
Event Type  Injury  
Event Description
We purchased autobrush toothbrushes, which do not actually clean teeth as they claim.The child version has a mouthplate that, turns out, slips off easily and poses a choking hazard.It slipped out while my toddler was using it monday (b)(6) 2020), and he gagged before spitting it out.Though my toddler did not choke, i am worried for other toddlers.I am also incredibly worried for people who trust that this device is doing as it claims and brushing teeth, when in fact it is not.We used plaque tablets to check and this product's use has no effect at all.But if we hadn't done this, using this product in place of a toothbrush (as it is advertised to be a substitute for) would result in poor dental hygiene, which has myriad health consequences.This product needs to be investigated.Fda safety report id# (b)(4).
 
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Brand Name
AUTOBRUSH
Type of Device
TOOTHBRUSH, POWERED
Manufacturer (Section D)
AUTOBRUSH
MDR Report Key10448681
MDR Text Key204451330
Report NumberMW5096244
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 Voluntary
Reporter Occupation Patient
Type of Report Initial
Report Date 08/21/2020
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? Yes
Device Operator Lay User/Patient
Device Model Number2020
Was Device Available for Evaluation? Yes
Initial Date Manufacturer Received Not provided
Initial Date FDA Received08/24/2020
Was Device Evaluated by Manufacturer? No Information
Type of Device Usage N
Patient Sequence Number1
Patient Age3 YR
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