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 2020-01-08 for MIRADRY SYSTEM MD4000-MC manufactured by Miradry, Inc..

Event Text Entries

[174695723] Review of lot history records for the involved device confirmed manufacturing steps and processes were met and followed. Product met final inspection and testing requirements prior to shipment. The rate seen (86 worldwide reportable incidents out of estimated 223,000+ procedures performed to date) is approximately 0. 039% of the procedures and within the acceptable range as identified in risk analysis documentation.
Patient Sequence No: 1, Text Type: N, H10


[174695724] Clinic reported a patient who developed swelling, redness and pain in axilla 18 days post miradry treatment. Antibiotics (bactrim) and steroids were prescribed. However, the symptoms worsen. Another set of antibiotics (keflex) was prescribed with steroids. The pain improved but swelling remained. Eventually, the redness resolved. By 17 days post-treatment, the affected area became discolored and began to peel. Patient did not have signs of a fever. Clinic referred the patient to an urgent care/er for further treatment but the patient declined.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number3008082710-2020-00001
MDR Report Key9567100
Report SourceCOMPANY REPRESENTATIVE,CONSUM
Date Received2020-01-08
Date of Report2019-12-10
Date of Event2019-11-22
Date Mfgr Received2019-12-10
Device Manufacturer Date2019-07-26
Date Added to Maude2020-01-08
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 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 Received2020-01-08
Model NumberMD4000-MC
Catalog NumberMD4000-MC
Lot Number19H1174
OperatorHEALTH PROFESSIONAL
Device AvailabilityN
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 2020-01-08

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