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	Abscess (1690)
Type of Reportable Event	Serious Injury
Event or Problem Description
Customer had abscess and infection in underarm after treatment.Patient was prescribed antibiotics.

• Brand Name: MIRADRY SYSTEM
• Common Device Name: MICROWAVE DERMATOLOGIC SYSTEM
• Manufacturer (Section D): MIRADRY INC.; 2790 walsh avenue; santa clara CA 95051
• Manufacturer (Section G): MIRADRY INC.; 2790 walsh avenue; santa clara CA 95051
• Manufacturer Contact: sara zellers ; 2790 walsh avenue; santa clara, CA 95051
• MDR Report Key: 17862065
• Report Number: 3008082710-2023-70042
• Device Sequence Number: 5578336
• Product Code: OUB
• UDI-Device Identifier: 00853419006008
• UDI-Public: (01)00853419006008(11)220228
• 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
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 10/03/2023

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
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 10/03/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 02/28/2022
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 25 YR
• Patient Sex: Male
• Patient Ethnicity: Non Hispanic
• Patient Race: Asian