MAUDE Adverse Event Report: MIRADRY INC. MIRADRY SYSTEM; MICROWAVE DERMATOLOGIC SYSTEM

Model Number	MN-MD4000-MC
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	Numbness (2415)
Date of Event	03/11/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
¿ complaint from patient 1.From shoulder to the wrist, she feels the sensation of water flowing.2.When she makes a down position of her arm, feels tingling.However, when she raise her arm she does not feel tingling.3.1-2 months post the treatment, she felt severe pain throughout her arms but it was resolved.Sometimes she feels spontaneous pain.¿ assessment by doctor 1.09/may/23 : doctor recommended to wait 6-12months 2.03/mar/24 : a doctor who performed the treatment left a clinic so dr.Kim took over the patient to assess.There was no visible tight band on both arms.Patient complaint about 2 small nodules on rt.Underarm but doctor could see based on his assessment.Patient still complains about tingling sensation when she down her both arms.

• 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: sara zellers ; 721 charcot ave.; san jose, CA 95131
• MDR Report Key: 19174345
• Report Number: 3008082710-2024-70007
• Device Sequence Number: 7349632
• Product Code: OUB
• UDI-Device Identifier: 00853419006008
• UDI-Public: (01)00853419006008(11)190326
• Combination Product (Y/N): N
• Initial Reporter Country: KS
• 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
• Report Source: Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 04/24/2024

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
• Operator of Device: Health Professional
• 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: Not provided
• Initial Report FDA Received Date: 04/24/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 03/26/2019
• Is the Device Labeled for Single Use? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Age: 50 YR
• Patient Sex: Unknown
• Patient Weight: 46 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: Asian