inforMED
InjuryOUB

MIRADRY SYSTEM

Received Jul 31, 2024 · Event occurred Dec 1, 2023

Report 3008082710-2024-70013 · MDR key 19878922

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

NA · Unknown

  • Nerve Damage
  • Nerve Damage

Narrative

Description of Event or Problem

42-YEAR-OLD MALE, TREATED WITH MIRADRY IN (B)(6) 2023 FOR THE FIRST TIME. VERY SEVERE, INCOMPLETE, GRADE III AXONOTMESIS OF THE LATERAL CORD OF THE BRACHIAL PLEXUS, WHICH EXPLAINS SENSORY DISTURBANCES OF THE MEDIAN NERVE AFFECTING THE THUMB AND INDEX FINGER, AS WELL AS, COMPLETE ABSENCE OF RESPONSE OF THE RIGHT LATERAL CUTANEOUS ANTEBRACHIAL NERVE IN THE FOREARM. DENERVATION IN THE BICEPS BRACHII MUSCLE CLINICALLY SHOWING AMYOTROPHY WITH SEVERE PARESIS DERIVED FROM INCOMPLETE GRADE III AXONOTMESIS OF THE LATERAL CORD OF THE RIGHT BRACHIAL PLEXUS. INJURY IN THE TERMINAL EXTENSION OF THE RIGHT MEDIAN NERVE JUSTIFYING PARTIAL GRADE III AXONOTMESIS OF THE EVOKED MOTOR RESPONSES IN THE THENAR EMINENCE OF THE RIGHT HAND. POOR EVOLUTIONARY PROGNOSIS IN THE SHORT AND MEDIUM TERM FOR THE MOTOR AND SENSORY TERRITORY OF THE MUSCULOCUTANEOUS NERVE AND THE SENSORY FASCICLES OF THE LATERAL CORD THAT WILL FORM THE DIGITAL SENSORY FIBERS OF THE RIGHT HAND, THUMB, AND INDEX FINGER.