MIRADRY SYSTEM
Received Jul 15, 2026 · Event occurred Mar 24, 2025
Report 3008082710-2026-70019 · MDR key 25833987
Device
Generic name
Microwave Dermatologic System
Manufacturer
Miradry Inc.Model number
MN-MD4000-MCCatalog number
MN-MD4000-MC
Lot number
17H0292-EU
Product problems
- Adverse Event Without Identified Device or Use Problem
Patient
30 YR · Male
- Purulent Discharge
- Skin Infection
Narrative
Additional Manufacturer Narrative
THERE WAS NO DEVICE ISSUE REPORTED. BASED ON THE INFORMATION PROVIDED, THIS INCIDENT HAS BEEN DETERMINED TO BE A RARE RISK OF THE PROCEDURE WITH NO EVIDENCE OF DEVICE MALFUNCTION. INFECTION IS A KNOWN RARE RISK OF THE PROCEDURE AS IDENTIFIED IN RISK ANALYSES AND DEVICE LABELING.
Description of Event or Problem
AFTER THE MIRADRY PROCEDURE, THE PATIENT DEVELOPED VARIOUS INFECTIONS AT THE ANESTHETIC INJECTION SITES. PATIENT WAS TREATED WITH ANTIBIOTICS PROVIDED BY A GENERAL PRACTITIONER, NOT THE CLINIC WHO PERFORMED THE MIRADRY PROCEDURE. OVER A YEAR LATER THE PATIENT CONTINUES TO SUFFER FROM RECURRING INFECTIONS IN THE RIGHT AXILLA. THE PATIENT COMPLETED A REPEAT COURSE OF ANTIBIOTICS. THE SYMPTOMS CONTINUE TO PERSIST AND THEREFORE THE PATIENT CONTACTED THE CLINIC THAT PERFORMED THE MIRADRY PROCEDURE.