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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: PHILIPS SONICARE; CLEANCARE BRUSH HEAD
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PHILIPS SONICARE; CLEANCARE BRUSH HEAD Back to Search Results
Model Number HX702X
Device Problems Mechanical Problem (1384); Device Fell (4014)
Patient Problems Foreign Body In Patient (2687); Foreign Body Embolism (4439)
Event Date 09/04/2021
Event Type  malfunction  
Manufacturer Narrative
The event date is approximate.The device serial number or manufacturing number were not provided.Customer contact phone was not provided.Manufacture date not provided or identifiable.
 
Event Description
A consumer reported that their cleancare brush head was broken in customer's mouth and almost choked.No injury or property damage was reported.
 
Manufacturer Narrative
D4: the device model and serial numbers or manufacturing numbers were identified and updated.H4: manufacture date was identified and updated.Analysis results: the root cause of the customer's complaint was customer abuse.
 
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Brand Name
PHILIPS SONICARE
Type of Device
CLEANCARE BRUSH HEAD
MDR Report Key12508544
MDR Text Key272546499
Report Number3026630-2021-10035
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 NumberHX702X
Device Catalogue NumberHX7026/30
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer09/22/2021
Initial Date Manufacturer Received 09/04/2021
Initial Date FDA Received09/21/2021
Supplement Dates Manufacturer Received09/28/2021
Supplement Dates FDA Received09/30/2021
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured10/18/2019
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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