inforMED
InjuryOUB

MIRADRY SYSTEM

Received Mar 16, 2023 · Event occurred Feb 7, 2023

Report 3008082710-2023-70007 · MDR key 16554182

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

Female

  • Burn(s)
  • Burn(s)

Narrative

Description of Event or Problem

PATIENT DEVELOPED BURNS AT THE TOP PART OF THE AXILLA.

Additional Manufacturer Narrative

DATA REVIEW WAS PERFORMED AND FOUND NO ISSUES WITH THE SYSTEM THAT WOULD HAVE CAUSED THE BURN.