inforMED
InjuryOUB

MIRADRY SYSTEM

Received Feb 10, 2021 · Event occurred Apr 27, 2019

Report 3008082710-2021-00001 · MDR key 11311074

Device

Generic name

Microwave Dermatologic System

Manufacturer

Sientra, Inc.

Model number

MD4000-MC

Product problems

  • Adverse Event Without Identified Device or Use Problem

Patient

Not reported

  • Unspecified Infection
  • Full thickness (Third Degree) Burn
  • Unspecified Infection
  • Full thickness (Third Degree) Burn

Narrative

Description of Event or Problem

PATIENT CONTACTED MIRADRY CONCERNING AN OPEN WOUND IN THE AXILLA TWO WEEKS POST SECOND TREATMENT. THE PATIENT SUBSEQUENTLY WAS DIAGNOSED WITH AN INFECTED THIRD DEGREE BURN AT A HOSPITAL.