InjuryOUB
MIRADRY SYSTEM
Received Dec 7, 2022 · Event occurred Feb 11, 2022
Report 3008082710-2022-70040 · MDR key 15933243
Device
Generic name
Microwave Dermatologic System
Manufacturer
Miradry Inc.Model number
MN-MD4000-MCCatalog number
MN-MD4000-MC
Lot number
222
Product problems
- Adverse Event Without Identified Device or Use Problem
- Adverse Event Without Identified Device or Use Problem
Patient
41 YR · Female
- Subcutaneous Nodule
- Subcutaneous Nodule
Narrative
Description of Event or Problem
PATIENT DEVELOPED AN AXILLARY NODULE. AUGMENTIN WAS PRESCRIBED. IRRIGATION AND DEBRIDEMENT WAS PERFORMED WITH PACKING FOR SYMPTOM RESOLUTION. NODULE WAS RESOLVED ON (B)(6) 2022.
Additional Manufacturer Narrative
A REVIEW OF CONSOLE DATA INDICATED NO ISSUES WITH THE DEVICE THAT WOULD CAUSE NODULES.