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	Skin Erosion (2075)
Date of Event	05/01/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
A data review was conducted against the device and there was no indication of a device malfunction.
Event or Problem Description
Patient complaining of post inflammatory ulcers on left axilla arm post tx.On (b)(6) 2025 see update: ulcerative lesion was observed.Surgical debridement was conducted, followed by saline irrigation and protection with appropriate dressing.The patient condition has improved and this will not be reported to regulatory authorities.

• Brand Name: MIRADRY SYSTEM
• Common Device Name: MICROWAVE DERMATOLOGIC SYSTEM
• Manufacturer (Section D): MIRADRY INC.; 721 charcot ave; san jose CA 95131
• Manufacturer (Section G): MIRADRY INC.; 721 charcot ave; san jose CA 95131
• Manufacturer Contact: miguel reyes ; 721 charcot ave; san jose, CA 95131
• MDR Report Key: 22028013
• Report Number: 3008082710-2025-70006
• Device Sequence Number: 12792950
• Product Code: OUB
• UDI-Device Identifier: 00853419006008
• UDI-Public: (01)00853419006008(11)210803
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• 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
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 05/08/2025

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: 05/08/2025
• Initial Report FDA Received Date: 05/15/2025
• Date Device Manufactured: 08/03/2021
• Patient Sequence Number: 1
• Patient Age: 26 YR
• Patient Sex: Male
• Patient Ethnicity: Non Hispanic