inforMED
InjuryOUB

MIRADRY SYSTEM

Received Aug 28, 2025 · Event occurred Jun 11, 2025

Report 3008082710-2025-70026 · MDR key 22919819

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

34 YR · Male

  • Burn(s)
  • Necrosis
  • Burn(s)
  • Necrosis

Narrative

Description of Event or Problem

PATIENT HAS NO PRE-EXISTING CONDITIONS. POST-TX, PATIENT DEVELOPED BILATERAL BURN BLISTERS THAT SUBSEQUENTLY PROGRESSED TO LOCALIZED SKIN NECROSIS. MULTIPLE SURGICAL PROCEDURES WERE PERFORMED TO COMPLETELY REMOVE THE NECROTIC TISSUE. PATIENT IS CURRENTLY IN THE HEALING PHASE WITH REGULAR WOUND CARE PROVIDED. SUPPORTIVE MEDICATIONS (E.G., ANTIBIOTICS, PAIN MANAGEMENT, IF APPLICABLE) WERE ADMINISTERED TO PREVENT INFECTION AND PROMOTE HEALING.