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	Neuropathy (1983)
Date of Event	01/09/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
Patient returned to clinic with lingering numbness in left axilla 11 months after receiving second miradry treatment.Referred to a hand orthopedist.
Additional Manufacturer Narrative
There was no device issue reported.Based on the information provided, this incident has been determined to be a rare risk of the procedure with no evidence of device malfunction.

• 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: cynthia kada ; 721 charcot ave; san jose, CA 95131
• MDR Report Key: 23936893
• Report Number: 3008082710-2025-70045
• Device Sequence Number: 18503718
• Product Code: OUB
• UDI-Device Identifier: 00853419006008
• UDI-Public: 010085341900600811170217
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K180396
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Consumer,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 12/04/2025

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
• Device Lot Number: 16H2530
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 12/04/2025
• Initial Report FDA Received Date: 12/31/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 02/17/2017
• 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
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Age: 43 YR
• Patient Sex: Female
• Patient Weight: 48 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: Asian