inforMED
InjuryOUB

MIRADRY SYSTEM

Received Oct 5, 2022 · Event occurred Sep 7, 2022

Report 3008082710-2022-70033 · MDR key 15544491

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

Female

  • Nerve Damage
  • Nerve Damage

Narrative

Description of Event or Problem

17 WEEKS POST-TX THE PATIENT IS EXPERIENCING A LARGE, LUMP BILATERALLY (THE RIGHT SIDE IS BIGGER) THEY STILL HAVE A "ZING" IN THEIR PINKY AND RING FINGER WHEN THEY MOVES THEIR ARM A CERTAIN WAY.