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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: PHILIPS ORAL HEALTHCARE, LLC PHILIPS SONICARE; PHILIPS SONICARE BRUSH HEAD
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PHILIPS ORAL HEALTHCARE, LLC PHILIPS SONICARE; PHILIPS SONICARE BRUSH HEAD Back to Search Results
Device Problem Detachment of Device or Device Component (2907)
Patient Problem Skin Inflammation/ Irritation (4545)
Event Date 04/04/2023
Event Type  Injury  
Manufacturer Narrative
B3: the event date is approximate.E1: the consumer contact information was not provided.G3: the complaint was received from a consumer in the united kingdom.H4: manufacture date not provided or identifiable.Product was not returned to confirm a malfunction has occurred.H3 other text : product not returned to manufacturer.
 
Event Description
A consumer reported that a philips sonicare brush head broke into pieces during use.A minor injury that did not require medical intervention was reported.
 
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Brand Name
PHILIPS SONICARE
Type of Device
PHILIPS SONICARE BRUSH HEAD
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 Key16777589
MDR Text Key313662318
Report Number3026630-2023-00037
Device Sequence Number1
Product Code JEQ
Combination Product (y/n)N
Reporter Country CodeUK
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 Received04/20/2023
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Lay User/Patient
Was Device Available for Evaluation? No
Date Manufacturer Received04/04/2023
Was Device Evaluated by Manufacturer? No
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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