inforMED
InjuryOUB

MIRADRY SYSTEM

Received Dec 8, 2022 · Event occurred Jul 8, 2022

Report 3008082710-2022-70041 · MDR key 15944110

Device

Generic name

Microwave Dermatologic System

Manufacturer

Miradry Inc.

Model number

MN-MD4000-MC

Catalog number

MN-MD4000-MC

Lot number

222

Product problems

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

Patient

24 YR · Female

  • Abscess
  • Abscess

Narrative

Additional Manufacturer Narrative

A REVIEW OF CONSOLE DATA INDICATED NO ISSUES WITH THE DEVICE THAT WOULD CAUSE ABSCESSES.

Description of Event or Problem

PATIENT DEVELOPED AN ABSCESS ON THEIR RIGHT AXILLA. CULTURE WAS TAKEN AND IRRIGATION AND DEBRIDEMENT COMPLETED. ABSCESS WAS RESOLVED ON (B)(6) 2022.