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	Swelling/ Edema (4577)
Date of Event	11/08/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
Patient had first md tx in (b)(6) 2023 and called the clinic last week stating she had some bumps under both axilla since 1 month.Patient states both bumps are the same size (small egg) and it feels sensitive upon touch and movement.Patient has no other symptoms.Pt had follow up with doctor who performed elliptical biopsy-fibroscar rearrangement and treated the pt with kenalog injection on (b)(6).
Additional Manufacturer Narrative
A data review was conducted against the device and there was no indication of a device malfunction.This mdr is being submitted late, as the initial submission on (b)(6) 2024 failed.This was determined to be an issue with fda¿s system accepting miradry¿s renewed ssl/signing and encryption certificate, which had a leading zero in the serial number.This was determined to be the cause of the mdr submission failure.Following troubleshooting with the esg help desk, a new certificate was obtained and uploaded, and the subsequent mdr submission on (b)(6) 2024 was successful.

• 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: angelica lopez ; 721 charcot ave; san jose, CA 95131
• MDR Report Key: 21158404
• Report Number: 3008082710-2024-70022
• Device Sequence Number: 18041311
• Product Code: OUB
• UDI-Device Identifier: 00853419006008
• UDI-Public: (01)00853419006008(11)190430
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• 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): 11/08/2024

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
• 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: 11/08/2024
• Initial Report FDA Received Date: 01/15/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 04/30/2019
• Patient Sequence Number: 1
• Patient Age: 25 YR
• Patient Sex: Female
• Patient Weight: 52 KG
• Patient Ethnicity: Non Hispanic