MIRADRY SYSTEM
Received Mar 3, 2022 · Event occurred Feb 3, 2022
Report 3008082710-2022-70004 · MDR key 13664093
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
47 YR · Female
- Numbness
- Numbness
Narrative
Description of Event or Problem
THE PATIENT CALLED THE TREATING PHYSICIAN TO REPORT SOME NUMBNESS POST TX AND WAS INSTRUCTED TO STRETCH TO SEE IF THAT WOULD HELP IMPROVE THE FEELING. THE PATIENT STATED SEVERAL DAYS LATER THAT THEY WERE STILL EXPERIENCING NUMBNESS, PARTICULARLY ON THE LEFT SIDE AND NOW THEY WERE ALSO EXPERIENCING SHOOTING PAIN THAT RUNS FROM THE INSIDE OF THEIR ELBOW TO THEIR WRIST. ON (B)(6) 2022, THE PHYSICIAN STATED THAT THEY WERE ABLE TO MASSAGE THE AFFECTED AREA AND THE ISSUE IS RESOLVED.
Additional Manufacturer Narrative
A REVIEW OF DATA OF THE SYSTEM INDICATED THE SYSTEM IS OPERATING FUNCTIONALLY. THERE IS NO INDICATION OF DOUBLE PASSES.