MIRADRY SYSTEM
Received Apr 24, 2024 · Event occurred Mar 11, 2024
Report 3008082710-2024-70007 · MDR key 19174345
Device
Generic name
Microwave Dermatologic System
Manufacturer
Miradry Inc.Model number
MN-MD4000-MCCatalog number
MN-MD4000-MC
Product problems
- Insufficient Device Problem Information
- Insufficient Device Problem Information
Patient
50 YR · Unknown
- Numbness
- Numbness
Narrative
Description of Event or Problem
¿ COMPLAINT FROM PATIENT 1. FROM SHOULDER TO THE WRIST, SHE FEELS THE SENSATION OF WATER FLOWING. 2. WHEN SHE MAKES A DOWN POSITION OF HER ARM, FEELS TINGLING. HOWEVER, WHEN SHE RAISE HER ARM SHE DOES NOT FEEL TINGLING. 3. 1-2 MONTHS POST THE TREATMENT, SHE FELT SEVERE PAIN THROUGHOUT HER ARMS BUT IT WAS RESOLVED. SOMETIMES SHE FEELS SPONTANEOUS PAIN. ¿ ASSESSMENT BY DOCTOR 1. 09/MAY/23 : DOCTOR RECOMMENDED TO WAIT 6-12MONTHS 2. 03/MAR/24 : A DOCTOR WHO PERFORMED THE TREATMENT LEFT A CLINIC SO DR. KIM TOOK OVER THE PATIENT TO ASSESS. THERE WAS NO VISIBLE TIGHT BAND ON BOTH ARMS. PATIENT COMPLAINT ABOUT 2 SMALL NODULES ON RT. UNDERARM BUT DOCTOR COULD SEE BASED ON HIS ASSESSMENT. PATIENT STILL COMPLAINS ABOUT TINGLING SENSATION WHEN SHE DOWN HER BOTH ARMS.