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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: PHILIPS ORAL HEALTHCARE, LLC PHILIPS SONICARE; PHILIPS ONE POWER TOOTHBRUSH

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PHILIPS ORAL HEALTHCARE, LLC PHILIPS SONICARE; PHILIPS ONE POWER TOOTHBRUSH Back to Search Results
Model Number HY120P
Device Problem Sparking (2595)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 06/13/2022
Event Type  malfunction  
Manufacturer Narrative
Date of event: the event date is approximate.
 
Event Description
A consumer alleged that their philips one power toothbrush device was burning down the base and sparking.No property damage and no injury were reported.
 
Manufacturer Narrative
Product was returned to confirm a malfunction has occurred.Analysis results: the root cause of the customer's complaint was a melted charge port.
 
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Brand Name
PHILIPS SONICARE
Type of Device
PHILIPS ONE 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
imke overdevest
22100 bothell everett highway
bothell, WA 98021
4254877000
MDR Report Key14941366
MDR Text Key302684837
Report Number3026630-2022-00078
Device Sequence Number1
Product Code JEQ
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
EXEMPT
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Consumer
Reporter Occupation Non-Healthcare Professional
Type of Report Initial,Followup
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received07/07/2022
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Lay User/Patient
Device Model NumberHY120P
Device Catalogue NumberHY1200/05
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Manufacturer Received10/25/2022
Was Device Evaluated by Manufacturer? Yes
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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