InjuryOUB
MIRADRY SYSTEM
Received Mar 28, 2025 · Event occurred Sep 23, 2024
Report 3008082710-2025-70004 · MDR key 21726911
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
NA · Unknown
- Swelling/ Edema
- Swelling/ Edema
Narrative
Additional Manufacturer Narrative
A DATA REVIEW WAS CONDUCTED AGAINST THE DEVICE AND THERE WAS NO INDICATION OF A DEVICE MALFUNCTION.
Description of Event or Problem
CLINIC REACHED OUT STATING THE PATIENT IS NOW COMPLAINING ABOUT A NERVE SENSATION DOWN GOING DOWN THEIR ARM AFTER TX. CLINIC WANTED SOMEONE IN CLINICAL TO GIVE DR. CHEN A CALL TO SEE IF WE HAD SEEN THIS HAPPEN BEFORE AND IF WE HAVE ANY ADVICE FOR THE PATIENT.