MIRADRY SYSTEM MD4000-MC

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,consum report with the FDA on 2019-09-27 for MIRADRY SYSTEM MD4000-MC manufactured by Miradry, Inc..

MAUDE Entry Details

Report Number3008082710-2019-00072
MDR Report Key9131462
Report SourceCOMPANY REPRESENTATIVE,CONSUM
Date Received2019-09-27
Date of Report2019-08-30
Date of Event2019-08-15
Date Mfgr Received2019-08-30
Device Manufacturer Date2016-08-31
Date Added to Maude2019-09-27
Event Key0
Report Source CodeManufacturer report
Manufacturer LinkY
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag3
Reporter OccupationPHYSICIAN ASSISTANT
Health Professional3
Initial Report to FDA3
Report to FDA3
Event Location3
Manufacturer ContactMS. SARA NAKAMURA
Manufacturer Street2790 WALSH AVENUE
Manufacturer CitySANTA CLARA CA 95051
Manufacturer CountryUS
Manufacturer Postal95051
Manufacturer Phone4089408700
Manufacturer G1MIRADRY, INC.
Manufacturer Street2790 WALSH AVENUE
Manufacturer CitySANTA CLARA CA 95051
Manufacturer CountryUS
Manufacturer Postal Code95051
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameMIRADRY SYSTEM
Generic NameMICROWAVE DERMATOLOGIC SYSTEM
Product CodeOUB
Date Received2019-09-27
Model NumberMD4000-MC
Catalog NumberMD4000-MC
Lot Number16H0849
Device AvailabilityN
Device AgeDA
Device Eval'ed by MfgrR
Device Sequence No1
Device Event Key0
ManufacturerMIRADRY, INC.
Manufacturer Address2790 WALSH AVENUE SANTA CLARA CA 95051 US 95051


Patients

Patient NumberTreatmentOutcomeDate
101. Required No Informationntervention 2019-09-27

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