MIRADRY SYSTEM
Received Jun 27, 2025 · Event occurred May 30, 2025
Report 3008082710-2025-70013 · MDR key 22352226
Device
Generic name
Microwave Dermatologic System
Manufacturer
Miradry Inc.Model number
MN-MD4000-MCCatalog number
MN-MD4000-MC
Product problems
- Adverse Event Without Identified Device or Use Problem
- Adverse Event Without Identified Device or Use Problem
Patient
15 YR · Male
- Bacterial Infection
- Bacterial Infection
Narrative
Description of Event or Problem
(B)(6) - PATIENT VISITED PHYSICIAN COMPLAINING OF REDNESS AND PAIN IN RIGHT AXILLA. ALSO STATING THEY SAW THEIR PRIMARY CARE PROVIDER AS WAS PRESCRIBED CEPHALEXIN BID, AND AFTERWARDS AS SWITCHED TO BACTRIM DC. C/O "BUMPS" ON BOTH AXILLA, WITH REDNESS AND PAIN ONLY TO RIGHT. PHYSICIAN ALSO ADMINISTERED 1/2 CC INJECTION OF KENALOG 40 MIXED WITH 1/2 CC 1/4% MARCAINE TO RIGHT AXILLARY NODULES. (B)(6) - VISITED PHYSICIAN TO REPORT RIGHT AXILLA RESPONDED WELL BUT FURTHER DEVELOPED SWELLING, PAIN, AND REDNESS. ON EXAM, LEFT AXILLA RESOLVED, BUT RIGHT AXILLA CONTAINED LARGE "EGG" SIZED FLUCTUANT. THIS WAS DRAINED WITH 18G NEEDLE AND DRESSED, SAMPLES WERE TAKEN FOR TESTING WITH PATIENT RX AUGMENTIN 500MG QD. (B)(6) - PATIENT VISITED HOSPITAL TO HAVE RIGHT AXILLA DRAINED. DRAIN WAS ALSO PLACED AND PATIENT SWITCHED PRESCRIPTION TO BACTRIM. TESTS CAME BACK AS STAPHYLOCOCCUS AUREUS. (B)(6) - PATIENT IS BETTER WITH SWELLING AND INFECTION RESOLVING.