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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: PHILIPS ORAL HEALTHCARE, LLC UNKNOWN; CHARGER

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PHILIPS ORAL HEALTHCARE, LLC UNKNOWN; CHARGER Back to Search Results
Model Number HX9100
Device Problems Temperature Problem (3022); Appropriate Term/Code Not Available (3191)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 03/24/2022
Event Type  malfunction  
Manufacturer Narrative
The event date is approximate.The issue is reported to be with the accessory charger of the diamondclean power toothbrush system.The complaint was received from a consumer in (b)(6).
 
Event Description
A consumer reported that their diamondclean power toothbrush charging glass exploded.No property damage and no injury were reported.
 
Manufacturer Narrative
D1-d4: the product was returned to philips oral healthcare at bothell and failure analysis was performed and determined to be non authentic philips product.Therefore, no information is currently available describing the actual product brand name, product code, common device name, model number, serial number, or manufacturer contact information.The reporting manufacturer is philips oral healthcare.The actual manufacturer is unknown.G1: the reporting manufacturer is philips oral healthcare.Philips oral healthcare did not manufacture the product that was returned for analysis.H4: the actual date of manufacture is not known at this time as the product has been identified as not authentic philips product.H5: it is unknown how the counterfeit product labeled for single use or not.Analysis results: on 06/14/2022, the returned product was performed at philips oral healthcare lab and failure analysis identified that charger was not an authentic philips product as the cause of the consumer's complaint.Therefore, this case was re-reviewed and deemed to be not reportable.
 
Event Description
A consumer reported that their diamondclean power toothbrush charging glass exploded.No property damage and no injury were reported.06/14/2022, the returned product was performed at philips oral healthcare lab and failure analysis identified that charger was not an authentic philips product as the cause of the consumer's complaint.Therefore, this case was re-reviewed and deemed to be not reportable.
 
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Brand Name
UNKNOWN
Type of Device
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
chieu yeung
22100 bothell everett highway
bothell, WA 98021
4254877000
MDR Report Key14062454
MDR Text Key289878073
Report Number3026630-2022-00036
Device Sequence Number1
Product Code JEQ
Combination Product (y/n)N
Reporter Country CodeGM
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,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 NumberHX9100
Device Catalogue NumberHX9355/86
Was Device Available for Evaluation? Device Returned to Manufacturer
Initial Date Manufacturer Received 03/24/2022
Initial Date FDA Received04/08/2022
Supplement Dates Manufacturer Received06/14/2022
Supplement Dates FDA Received06/23/2022
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured11/06/2018
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Unknown
Patient Sequence Number1
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