inforMED
InjuryOUB

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-MC

Catalog 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.