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U.S. Department of Health and Human Services

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

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PHILIPS ORAL HEALTHCARE, LLC PHILIPS SONICARE; PROTECTIVECLEAN POWER TOOTHBRUSH Back to Search Results
Model Number HX685T
Device Problem Patient Device Interaction Problem (4001)
Patient Problem Tooth Fracture (2428)
Event Date 12/05/2019
Event Type  Injury  
Manufacturer Narrative
Outcomes to adverse event: the reported injury was a fine crack on the consumer's teeth.Report source: complaint received from (b)(6).
 
Event Description
A consumer alleged that a fine crack on their teeth during use of the protective clean power toothbrush.
 
Manufacturer Narrative
The product model was identified; revised lot # from not applicable (na) to no information (ni).Patient phone number was identified.Analysis results: product was not returned to confirm a malfunction has occurred.
 
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Brand Name
PHILIPS SONICARE
Type of Device
PROTECTIVECLEAN 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 Key9537036
MDR Text Key173556228
Report Number3026630-2019-00082
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,foreign
Reporter Occupation Non-Healthcare Professional
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? Yes
Is this a Product Problem Report? No
Device Operator Lay User/Patient
Device Model NumberHX685T
Device Catalogue NumberHX6877/54
Was Device Available for Evaluation? No
Distributor Facility Aware Date12/05/2019
Initial Date Manufacturer Received 12/06/2019
Initial Date FDA Received12/31/2019
Supplement Dates Manufacturer Received03/04/2020
Supplement Dates FDA Received03/10/2020
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse
Patient Sequence Number1
Patient Outcome(s) Other;
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