inforMED
InjuryOUB

MIRADRY SYSTEM

Received Apr 18, 2023 · Event occurred Mar 3, 2023

Report 3008082710-2023-70015 · MDR key 16765774

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

Unknown

  • Burn(s)
  • Burn(s)

Narrative

Additional Manufacturer Narrative

A DATA REVIEW WAS DONE AND THERE WERE NO ABNORMALITIES THAT WOULD HAVE CAUSED THIS ADVERSE EVENT.

Description of Event or Problem

PT HAD THEIR 2ND TX AND 9 DAYS POST TX THEY DEVELOPED A WOUND. THEY WERE PRESCRIBED ANTIBIOTIC OINTMENT AND TOLD TO KEEP GAUZE ON IT. PICTURES ATTACHED.