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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: PHILIPS SONICARE; FLEXCARE POWER TOOTHBRUSH

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PHILIPS SONICARE; FLEXCARE POWER TOOTHBRUSH Back to Search Results
Model Number HX6960
Device Problems Mechanical Problem (1384); Appropriate Term/Code Not Available (3191)
Patient Problem Vomiting (2144)
Event Date 08/10/2021
Event Type  malfunction  
Manufacturer Narrative
The event date is approximate.Customer contact information and mailing address were not provided.
 
Event Description
The consumer alleged that their flexcare power toothbrush metal pieces came out of toothbrush during use.No serious injury was reported.
 
Manufacturer Narrative
Analysis results: the root cause of the customer's complaint could not be determined as no functional fault could be found with the device.
 
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Brand Name
PHILIPS SONICARE
Type of Device
FLEXCARE POWER TOOTHBRUSH
MDR Report Key12317055
MDR Text Key266378841
Report Number3026630-2021-10029
Device Sequence Number1
Product Code JEQ
Combination Product (y/n)N
PMA/PMN Number
EXEMPT
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type consumer
Type of Report Initial,Followup
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Lay User/Patient
Device Model NumberHX6960
Device Catalogue NumberHX6921/04
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer09/08/2021
Distributor Facility Aware Date08/10/2021
Initial Date Manufacturer Received 08/10/2021
Initial Date FDA Received08/12/2021
Supplement Dates Manufacturer Received09/09/2021
Supplement Dates FDA Received09/21/2021
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured08/23/2018
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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