SONENDO GENTLEWAVE SYSTEM FG-002-00001

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,health report with the FDA on 2020-02-20 for SONENDO GENTLEWAVE SYSTEM FG-002-00001 manufactured by Sonendo.

MAUDE Entry Details

Report Number3010817521-2020-00001
MDR Report Key9736218
Report SourceCOMPANY REPRESENTATIVE,HEALTH
Date Received2020-02-20
Date of Report2020-02-20
Date of Event2019-10-10
Date Mfgr Received2019-12-10
Date Added to Maude2020-02-20
Event Key0
Report Source CodeManufacturer report
Manufacturer LinkY
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag3
Reporter OccupationDENTIST
Health Professional3
Initial Report to FDA3
Report to FDA3
Event Location3
Manufacturer ContactANGELA CHEN
Manufacturer Street26061 MERIT CIRCLE, SUITE 102
Manufacturer CityLAGUNA HILLS, CA
Manufacturer CountryUS
Manufacturer Phone7663636801
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameSONENDO GENTLEWAVE SYSTEM
Generic NameULTRASONIC SCALER
Product CodeELC
Date Received2020-02-20
Model NumberFG-002-00001
OperatorHEALTH PROFESSIONAL
Device AvailabilityN
Device Eval'ed by MfgrR
Device Sequence No1
Device Event Key0
ManufacturerSONENDO
Manufacturer Address26061 MERIT CIRCLE, SUITE 102 LAGUNA HILLS, CA US


Patients

Patient NumberTreatmentOutcomeDate
101. Other 2020-02-20

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