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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: PHILIPS ORAL HEALTHCARE, LLC PHILIPS SONICARE; DIAMOND CLEAN SMART CHARGER

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PHILIPS ORAL HEALTHCARE, LLC PHILIPS SONICARE; DIAMOND CLEAN SMART CHARGER Back to Search Results
Model Number CBA1001
Device Problem Excessive Heating (4030)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 02/17/2024
Event Type  malfunction  
Event Description
A consumer reported that the charging base was heating up and making smoke.Their granite table was disolored and burned.
 
Manufacturer Narrative
The event date is approximate.Product was not returned to confirm a malfunction has occurred.
 
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Brand Name
PHILIPS SONICARE
Type of Device
DIAMOND CLEAN SMART CHARGER
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
ellen patterson
22100 bothell everett highway
bothell, WA 98021
4254877000
MDR Report Key18788512
MDR Text Key336332690
Report Number3026630-2024-00012
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
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 NumberCBA1001
Device Catalogue NumberHX9924/01
Was Device Available for Evaluation? No
Initial Date Manufacturer Received 02/17/2024
Initial Date FDA Received02/27/2024
Was Device Evaluated by Manufacturer? No
Date Device Manufactured01/08/2018
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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