MAUDE Adverse Event Report: MIRADRY INC. MIRADRY SYSTEM; MICROWAVE DERMATOLOGIC SYSTEM

Model Number	MN-MD4000-MC
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Burn(s) (1757)
Date of Event	07/30/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
A review of system data was completed and found no issue with the system that would cause the adverse event.
Event or Problem Description
Received a complaint form from tim stating on 7/30 a treatment was completed, however during the patients return visit it was noticed the patient had burns.

• Brand Name: MIRADRY SYSTEM
• Common Device Name: MICROWAVE DERMATOLOGIC SYSTEM
• Manufacturer (Section D): MIRADRY INC.; 2790 walsh avenue; santa clara CA 95051
• Manufacturer (Section G): MIRADRY INC.; 2790 walsh avenue; santa clara CA 95051
• Manufacturer Contact: sara zellers ; 2790 walsh avenue; santa clara, CA 95051
• MDR Report Key: 17712125
• Report Number: 3008082710-2023-70036
• Device Sequence Number: 2226291
• Product Code: OUB
• UDI-Device Identifier: 00853419006008
• UDI-Public: (01)00853419006008(11)170713
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K1311162
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Consumer,Company Representative
• Initial Reporter Occupation: 505
• Type of Report: Initial
• Report Date (Section B): 09/08/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Model Number: MN-MD4000-MC
• Device Catalogue Number: MN-MD4000-MC
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 09/08/2023
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 07/13/2017
• Patient Sequence Number: 1
• Patient Sex: Unknown