MIRADRY SYSTEM
Received Oct 2, 2025 · Event occurred Aug 12, 2025
Report 3008082710-2025-70037 · MDR key 23206447
Device
Generic name
Microwave Dermatologic System
Manufacturer
Miradry Inc.Model number
MN-MD4000-MCCatalog number
MN-MD4000-MC
Lot number
UNKNOWN
Product problems
- Adverse Event Without Identified Device or Use Problem
- Adverse Event Without Identified Device or Use Problem
Patient
NA · Unknown
- Abscess
- Abscess
Narrative
Description of Event or Problem
PATIENT REPORTS PAIN AND SORENESS IN RIGHT AXILLA, FEVER, AND CHILLS STARTING (B)(6) 2025. PATIENT VISITED URGENT CARE AND WAS PRESCRIBED CEPHALEXIN. (B)(6) 2025 - FOLLOW UP EXAMINATION BY DR. (B)(6) REVEALED A LARGE SIZED FLUID-FILLED CYST IN THE RIGHT AXILLA, ALONG WITH TWO SMALLER HARD NODULES INFERIORLY. SKIN IS INTACT. DR. (B)(6) PRESCRIBED MEDROL PACK 4MG. (B)(6) 2025 - PATIENT REPORTED THAT FEVER AND CHILLS SYMPTOMS HAVE RETURNED DR. (B)(6) PRESCRIBED MINOCYCLINE 100MG CAPSULES. (B)(6) 2025 - DR. (B)(6) FOUND ABSCESS NOT RESOLVING, WITH PATIENT SYMPTOMS STILL PRESENT. PATIENT ADVISED BY DR TO SEE A DERMATOLOGIST OR THEIR GENERAL PRACTITIONER. IF UNABLE TO THEN ADVISED TO VISIT EMERGENCY ROOM TO TREAT.