inforMED
InjuryOUB

MIRADRY SYSTEM

Received Aug 7, 2023

Report 3008082710-2023-70034 · MDR key 17470260

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

  • Abscess
  • Abscess

Narrative

Description of Event or Problem

(B)(6) - PATIENT INFORMED ACCOUNT OPEN WOUND AND PAINFUL, MUPIROCIN BID, OTC IBUPROFEN AND LIDOCAINE CREAM. (B)(6)- PATIENT REPORT TO ACCOUNT THAT IT WAS PAINFUL NOT IMPROVING.

Additional Manufacturer Narrative

A REVIEW OF SYSTEM DATA WAS COMPLETED AND FOUND NO ISSUES WITH THE SYSTEM THAT WOULD HAVE CAUSED THE ADVERSE EVEMT.