PHILIPS SONICARE HX8340 HX8331/11

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a consumer,foreign report with the FDA on 2020-02-03 for PHILIPS SONICARE HX8340 HX8331/11 manufactured by Philips Oral Healthcare, Llc.

Event Text Entries

[189093904] The event date is approximate. Report source: complaint received from (b)(6).
Patient Sequence No: 1, Text Type: N, H10


[189093905] A consumer reported that their sonicare airfloss exploded while charging. No injury or property damage was reported.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number3026630-2020-00009
MDR Report Key9661914
Report SourceCONSUMER,FOREIGN
Date Received2020-02-03
Date of Event2020-01-28
Date Facility Aware2020-01-28
Date Mfgr Received2020-01-28
Device Manufacturer Date2016-03-31
Date Added to Maude2020-02-03
Event Key0
Report Source CodeManufacturer report
Manufacturer LinkY
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag3
Health Professional3
Initial Report to FDA3
Report to FDA3
Event Location3
Manufacturer ContactMR. CHIEU YEUNG
Manufacturer Street22100 BOTHELL EVERETT HIGHWAY
Manufacturer CityBOTHELL WA 98021
Manufacturer CountryUS
Manufacturer Postal98021
Manufacturer Phone4254877000
Manufacturer G1PHILIPS ORAL HEALTHCARE, LLC
Manufacturer Street22100 BOTHELL EVERETT HIGHWAY
Manufacturer CityBOTHELL WA 98021
Manufacturer CountryUS
Manufacturer Postal Code98021
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NamePHILIPS SONICARE
Generic NameAIRFLOSS PRO
Product CodeEFS
Date Received2020-02-03
Model NumberHX8340
Catalog NumberHX8331/11
OperatorLAY USER/PATIENT
Device AvailabilityN
Device Eval'ed by MfgrR
Device Sequence No1
Device Event Key0
ManufacturerPHILIPS ORAL HEALTHCARE, LLC
Manufacturer Address22100 BOTHELL EVERETT HIGHWAY BOTHELL WA 98021 US 98021


Patients

Patient NumberTreatmentOutcomeDate
101. Other 2020-02-03

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