MIRADRY SYSTEM
Received Jan 13, 2026 · Event occurred Oct 31, 2025
Report 3008082710-2026-70003 · MDR key 24064178
Device
Generic name
Microwave Dermatologic System
Manufacturer
Miradry Inc.Model number
MN-MD4000-MCCatalog number
MN-MD4000-MC
Lot number
20H0603-JP
Product problems
- Improper or Incorrect Procedure or Method
Patient
30 YR · Female
- Partial thickness (Second Degree) Burn
Narrative
Additional Manufacturer Narrative
THE MIRADRY SYSTEM LABELING INCLUDES A WARNING TO NOT TREAT THE SAME SITE TWICE IN A GIVEN SESSION. MULTIPLE TREATMENTS TO THE SITE MAY CAUSE SIGNIFICANT DAMAGE TO SUBDERMAL STRUCTURES. TREATMENT DATA REVIEWED CORRESPONDED WITH DUPLICATE TREATMENTS. NO SYSTEM MALFUNCTIONS WERE OBSERVED. REVIEW OF LOT HISTORY RECORDS FOR THE INVOLVED DEVICE CONFIRMED MANUFACTURING STEPS AND PROCESSES WERE MET AND FOLLOWED. PRODUCT MET FINAL INSPECTION AND TESTING REQUIREMENTS PRIOR TO SHIPMENT.
Description of Event or Problem
PATIENT RECEIVED SECOND MIRADRY TREATMENT IN BOTH AXILLA ON (B)(6) 2025, WITH 2 PASSES APPLIED TO ROWS 2 THROUGH 13. ON (B)(6) 2025, PATIENT PRESENTED WITH RIGHT AXILLARY SKIN ULCER SUSPECTED TO BE SECOND-DEGREE BURN. DEBRIDEMENT WITH APPLICATION OF PROSTAGLANDIN OINTMENT AND WOUND DRESSING PERFORMED(B)(6) 2025.