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 health professional report with the FDA on 2020-03-14 for MIRADRY SYSTEM MD4000-MC manufactured by Sientra, Inc..

Event Text Entries

[188027751] Analysis of treatment data recorded by the system revealed nothing unusual. There were no device performance or user issues observed that would cause the symptoms. The rate of abscess seen ((b)(4) of the procedures and within the acceptable range as identified in risk analysis documentation.
Patient Sequence No: 1, Text Type: N, H10


[188027752] Post miradry treatment patient had abscess and hematoma form in axilla. The patient was prescribed 100mg doxy to treat the abscess.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number3008082710-2020-00015
MDR Report Key9832757
Report SourceHEALTH PROFESSIONAL
Date Received2020-03-14
Date of Report2020-03-13
Date of Event2019-12-27
Date Mfgr Received2020-01-27
Date Added to Maude2020-03-14
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 ContactJOANN KUHNE
Manufacturer Street420 S FAIRVIEW AVE. SUITE 200
Manufacturer CitySANTA BARBARA, CA
Manufacturer CountryUS
Manufacturer Phone5623500
Manufacturer G1SIENTRA, INC.
Manufacturer Street420 S FAIRVIEW AVE. SUITE 200
Manufacturer CitySANTA BARBARA, CA
Manufacturer CountryUS
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameMIRADRY SYSTEM
Generic NameMICROWAVE DERMATOLOGIC SYSTEM
Product CodeOUB
Date Received2020-03-14
Model NumberMD4000-MC
Catalog NumberMD4000-MC
Lot Number17H0896
OperatorHEALTH PROFESSIONAL
Device AvailabilityN
Device Eval'ed by MfgrR
Device Sequence No1
Device Event Key0
ManufacturerSIENTRA, INC.
Manufacturer Address420 S FAIRVIEW AVE. SUITE 200 SANTA BARBARA, CA US


Patients

Patient NumberTreatmentOutcomeDate
101. Required No Informationntervention 2020-03-14

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