MIRADRY SYSTEM
Received May 15, 2026 · Event occurred Mar 18, 2026
Report 3008082710-2026-70012 · MDR key 25194172
Device
Generic name
Microwave Dermatologic System
Manufacturer
Miradry Inc.Model number
MN-MD4000-MCCatalog number
MN-MD4000-MC
Lot number
18H0095
Product problems
- Adverse Event Without Identified Device or Use Problem
Patient
46 YR · Male
- Abscess
Narrative
Description of Event or Problem
REP WAS NOTIFIED DURING VISIT OF A PATIENT WHO DEVELOPED AN ABCSESS 2 WEEKS POST TREATMENT POSSIBLY NOW RESOLVING. THE EVENT ARE OUTLINED AS FOLLOWS: ON (B)(6) 2026 - PATIENT PRESENTED ABSCESS AND WAS INCISED, DRAINED, AND PACKED BY DR. ON (B)(6) 2026 - VISIT COMPLETED TO IRRIGATE AND PACK WOUND. IMPROVEMENT NOTED. ON (B)(6) 2026 - VISIT COMPLETED WHERE WOUND RE-DRESSED AND BUT SHOWING FURTHER IMPROVEMENT.
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.