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U.S. Department of Health and Human Services

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

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PHILIPS ORAL HEALTHCARE, LLC PHILIPS SONICARE; DIAMONDCLEAN POWER TOOTHBRUSH Back to Search Results
Model Number HX9340
Device Problem Mechanical Problem (1384)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 12/02/2019
Event Type  Injury  
Event Description
The consumer alleged that the metal shaft from their diamondclean toothbrush fell off during use.No injuries were reported.A potential choking hazard was identified.
 
Manufacturer Narrative
Revised lot # from not applicable (na) to no information (ni).Analysis results: product was not returned to confirm a malfunction has occurred.
 
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Brand Name
PHILIPS SONICARE
Type of Device
DIAMONDCLEAN 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 Key9531472
MDR Text Key173081335
Report Number3026630-2019-00081
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
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Lay User/Patient
Device Model NumberHX9340
Device Catalogue NumberHX9332/05
Was Device Available for Evaluation? No
Distributor Facility Aware Date12/02/2019
Initial Date Manufacturer Received 12/02/2019
Initial Date FDA Received12/30/2019
Supplement Dates Manufacturer Received01/22/2020
Supplement Dates FDA Received03/10/2020
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured04/18/2013
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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