MIRADRY SYSTEM

Additional Manufacturer Narrative

THE MIRADRY SYSTEM LABELING INCLUDES A WARNING TO NOT TREAT THE SAME SITE TWICE IN A GIVEN SESSION. MULTIPLE TREATMENTS TO THE SITE MAY CAUSE SIGNIFICANT DAMAGE TO SUBDERMAL STRUCTURES. TREATMENT DATA REVIEWED CORRESPONDED WITH DUPLICATE TREATMENTS. NO SYSTEM MALFUNCTIONS WERE OBSERVED. REVIEW OF LOT HISTORY RECORDS FOR THE INVOLVED DEVICE CONFIRMED MANUFACTURING STEPS AND PROCESSES WERE MET AND FOLLOWED. PRODUCT MET FINAL INSPECTION AND TESTING REQUIREMENTS PRIOR TO SHIPMENT.

Description of Event or Problem

ON (B)(6) 2025, THE NURSE PERFORMED THE SECOND PASS OF TREATMENT TO THE LEFT AXILLA. WHILE DELIVERING THE THIRD ROW, THE PATIENT COMPLAINED OF PAIN IN THE LEFT HAND. AN ADDITIONAL 30 ML OF ANESTHETIC WAS ADMINISTERED, AND THE AREA WAS RETREATED. NO PAIN OCCURRED DURING THE RETREATMENT, AND THE PROCEDURE WAS COMPLETED. ON (B)(6) 2025, THE PATIENT CONTACTED THE CLINIC REPORTING NUMBNESS AND WEAKNESS IN THE LEFT HAND, AFFECTING THE FIRST THROUGH FOURTH FINGERS. PATIENT WILL BE ASKED TO VISIT THE CLINIC, AND VITAMIN B12 WILL BE PRESCRIBED.