inforMED
InjuryOUB

MIRADRY SYSTEM

Received Mar 24, 2025 · Event occurred Nov 26, 2024

Report 3008082710-2025-70002 · MDR key 21679579

Device

Generic name

Microwave Dermatologic System

Manufacturer

Miradry Inc.

Model number

MN-MD4000-MC

Catalog number

MN-MD4000-MC

Product problems

  • Adverse Event Without Identified Device or Use Problem
  • Adverse Event Without Identified Device or Use Problem

Patient

18 YR · Female

  • 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

ABSCESS SHOWED UP ON PT ABOUT 2 WEEKS POST TX. ATTEMPTED TO ASPIRATE 2X AND KEPT FILLING BACK UP. PT HAS ABSCESS LANCED BY SURGEON, CLINIC PLACED A WICK IN THE ABSCESS, PT WAS ADVISED TO WASH WITH SOAP AND WATER TWICE DAILY AND ISSUE IS NOW RESOLVING.