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	Burn(s) (1757)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
A review of system data indicated that there is no issue with the device that would cause the adverse event.
Event or Problem Description
3rd degree burn.Post tx cleansed with alcohol and applied bacitracin on top of area treated.Pt was to cleanse treated area w hibiclense and then applied bacitracin 2x that day, then 3xs next day.Pt was given 500mg iboprofen, and told to take every 4 hrs for day one.

• 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: 18553572
• Report Number: 3008082710-2024-70005
• Device Sequence Number: 7700214
• Product Code: OUB
• UDI-Device Identifier: 00853419006008
• UDI-Public: (01)00853419006008(11)180730
• Combination Product (Y/N): N
• Initial Reporter State: CO
• 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
• Report Source: Consumer,Company Representative
• Initial Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date (Section B): 01/22/2024

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?: Yes
• 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: 01/22/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 07/30/2018
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 50 YR
• Patient Sex: Female