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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: PHILIPS ORAL HEALTHCARE, LLC PHILIPS SONICARE; HEALTHYWHITE POWER TOOTHBRUSH
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PHILIPS ORAL HEALTHCARE, LLC PHILIPS SONICARE; HEALTHYWHITE POWER TOOTHBRUSH Back to Search Results
Model Number HX6710
Device Problem Temperature Problem (3022)
Patient Problem Electric Shock (2554)
Event Date 01/11/2022
Event Type  malfunction  
Event Description
A consumer alleged that their healthy white power toothbrush exploded.The customer report a minor electrical shocks when he touched the device.No other injury and property damage were reported.
 
Manufacturer Narrative
The event date is approximate.The complaint was received from a consumer in (b)(4).Analysis results: product was not returned to confirm a malfunction has occurred.Product not returned to manufacturer.
 
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Brand Name
PHILIPS SONICARE
Type of Device
HEALTHYWHITE POWER TOOTHBRUSH
Manufacturer (Section D)
PHILIPS ORAL HEALTHCARE, LLC
22100 bothell everett highway
bothell WA 98021
Manufacturer (Section G)
PHILIPS ORAL HEALTHCARE, LLC
22100 bothell everett highway
bothell WA 98021
Manufacturer Contact
chieu yeung
22100 bothell everett highway
bothell, WA 98021
4254877000
MDR Report Key13300917
MDR Text Key284524810
Report Number3026630-2022-00010
Device Sequence Number1
Product Code JEQ
Combination Product (y/n)N
Reporter Country CodeNL
PMA/PMN Number
EXEMPT
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Foreign,Consumer
Reporter Occupation Non-Healthcare Professional
Type of Report Initial
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received01/20/2022
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Lay User/Patient
Device Model NumberHX6710
Device Catalogue NumberHX6712/43
Was Device Available for Evaluation? No
Date Manufacturer Received01/11/2022
Was Device Evaluated by Manufacturer? No
Date Device Manufactured12/08/2016
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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