inforMED
InjuryOUB

MIRADRY SYSTEM

Received Dec 31, 2025 · Event occurred Jan 9, 2025

Report 3008082710-2025-70045 · MDR key 23936893

Device

Generic name

Microwave Dermatologic System

Manufacturer

Miradry Inc.

Model number

MN-MD4000-MC

Catalog number

MN-MD4000-MC

Lot number

16H2530

Product problems

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

Patient

43 YR · Female

  • Neuropathy
  • Neuropathy

Narrative

Description of Event or Problem

PATIENT RETURNED TO CLINIC WITH LINGERING NUMBNESS IN LEFT AXILLA 11 MONTHS AFTER RECEIVING SECOND MIRADRY TREATMENT. REFERRED TO A HAND ORTHOPEDIST.

Additional Manufacturer Narrative

THERE WAS NO DEVICE ISSUE REPORTED. BASED ON THE INFORMATION PROVIDED, THIS INCIDENT HAS BEEN DETERMINED TO BE A RARE RISK OF THE PROCEDURE WITH NO EVIDENCE OF DEVICE MALFUNCTION.