MIRADRY SYSTEM
Received Oct 2, 2025 · Event occurred Aug 22, 2025
Report 3008082710-2025-70036 · MDR key 23206446
Device
Generic name
Microwave Dermatologic System
Manufacturer
Miradry Inc.Model number
MN-MD4000-MCCatalog number
MN-MD4000-MC
Lot number
22H1095-JP
Product problems
- Adverse Event Without Identified Device or Use Problem
- Adverse Event Without Identified Device or Use Problem
Patient
NA · Female
- Nerve Damage
- Nerve Damage
Narrative
Description of Event or Problem
PATIENT PRESENTING NUMBNESS OF RIGHT HAND. PATIENT RETURNED TO CLINIC (B)(6) 2025 AND WAS PRESCRIBED METHYCOBAL WITH THE DR REFLECTED THE FOLLOWING FROM HER VISIT: -SHE HAD ACTUALLY STARTED TO FEEL PAIN JUST AFTER THE TX. -THE AREA WHERE SHE FELT PAIN IS MAINLY FROM HER SHOULDER TO ELBOW. - THE PAIN IS LIKE WHEN HITTING HER ELBOW - THE PAIN CYCLE IS IRREGULAR AND IT HURTS WHEN SHE MOVES HER ARMS. FREQUENCY OF THE PAIN IS INCREASING - SHE CAN MOVE HER ARMS, AND HER ARMS ARE NOT SWOLLEN. ALSO, THE DOCTOR FOUND NO IRREGULAR INCLUDING NO TIGHTNESS AND STIFFNESS ON HER AXILLA. -THE RIGHT HAND FEELS IT SEVERAL TIME A DAY DR STATES POSSIBLE NERVE DAMAGE. (B)(6) 2025 - ADDITIONAL INFORMATION PROVIDED REFLECTING HOW AT THE BEGINNING OF TREATMENT PATIENT FELT PAIN, AND AN ADDITIONAL 40CC TO THE LEFT SIDE, AS WELL AS 20CC TO THE RIGHT OF ANESTHESIA WAS ADMINISTERED. NERVE INJURY IS A POTENTIAL RISK WITH SYMPTOMS EXPECTED TO FULLY RESOLVE OVER TIME.
Additional Manufacturer Narrative
REVIEW OF LOT HISTORY RECORDS FOR THE INVOLVED DEVICE CONFIRMED MANUFACTURING STEP AND PROCESSES WERE MET AND FOLLOWED. PRODUCT MET FINAL INSPECTION AND TESTING REQUIREMENTS PRIOR TO SHIPMENT.