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	09/26/2024
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.This mdr is being submitted late, as the initial submission on november 12, 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 december 19, 2024 was successful.
Event or Problem Description
Received email from rep stating the patient is experiencing 10/10 nerve & discomfort bilateral that is ongoing post 2nd tx.Patient was rx gabapentin and medrol dose pack and advised to massage and stretch.

• 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: 21154367
• Report Number: 3008082710-2024-70019
• Device Sequence Number: 15785322
• Product Code: OUB
• UDI-Device Identifier: 00853419006008
• UDI-Public: (01)00853419006008(11)190530
• Combination Product (Y/N): N
• Initial Reporter State: OH
• 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): Unknown
• Reporter Type: Manufacturer
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 10/23/2024

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
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 10/23/2024
• Initial Report FDA Received Date: 01/14/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 05/30/2019
• Patient Sequence Number: 1
• Patient Age: 28 YR
• Patient Sex: Female
• Patient Weight: 61 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White