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	Cellulitis (1768)
Date of Event	01/19/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
The patient developed cellulitis to left axilla.The patient needed antibiotics (doxycycline & keflex) & wound care for their abscess.The issue is resolving.
Additional Manufacturer Narrative
A review of the system data was performed on (b)(6) 2023 and there was no issues found that would have caused the adverse event.

• 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: 2790 walsh avenue; santa clara, CA 95051
• MDR Report Key: 16419159
• Report Number: 3008082710-2023-70005
• Device Sequence Number: 5362629
• Product Code: OUB
• UDI-Device Identifier: 00853419006008
• UDI-Public: (01)00853419006008(11)180619
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K1311162
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 02/22/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Model Number: MN-MD4000-MC
• Device Catalogue Number: MN-MD4000-MC
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 02/22/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 06/19/2018
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: HANDPIECE: 22HO226-HPBIOTIP: 22H0458
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 25 YR
• Patient Sex: Male
• Patient Weight: 95 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White