MIRADRY UNK

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2019-10-11 for MIRADRY UNK manufactured by Sientra / Miradry, Inc..

MAUDE Entry Details

Report NumberMW5090358
MDR Report Key9192096
Date Received2019-10-11
Date of Report2019-10-09
Date of Event2018-07-13
Date Added to Maude2019-10-15
Event Key0
Report Source CodeVoluntary report
Manufacturer LinkN
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag3
Reporter OccupationPATIENT
Health Professional3
Initial Report to FDA3
Report to FDA3
Event Location3
Single Use3
Previous Use Code3
Event Type3
Type of Report0

Device Details

Brand NameMIRADRY
Generic NameINSTRUMENT FOR TREATMENT OF HYPERHIDROSIS
Product CodeOUB
Date Received2019-10-11
Model NumberUNK
Catalog NumberUNK
Lot NumberUNK
OperatorHEALTH PROFESSIONAL
Device AvailabilityN
Device Eval'ed by MfgrI
Device Sequence No1
Device Event Key0
ManufacturerSIENTRA / MIRADRY, INC.


Patients

Patient NumberTreatmentOutcomeDate
101. Life Threatening; 2. Deathisabilit 2019-10-11

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