MIRADRY SYSTEM

Description of Event or Problem

CLINIC REPORTED LEAN/THIN PATIENT TREATED EARLIER IN THE DAY COMPLAINING OF NUMBNESS DOWN ARM AFFECTING GRIP STRENGTH. PATIENT SUBSEQUENTLY WENT TO THE ER (DATE UNKNOWN) AND WAS EXPECTED TO SEE A NEUROLOGIST FOR FURTHER EVALUATION.

Additional Manufacturer Narrative

THERE WERE NO DEVICE ISSUES REPORTED BY THE USER. REVIEW OF LOT HISTORY RECORDS FOR THE INVOLVED DEVICE CONFIRMED MANUFACTURING STEP AND PROCESSES WERE MET AND FOLLOWED. PRODUCT MET FINAL INSPECTION AND TESTING REQUIREMENTS PRIOR TO SHIPMENT. NERVE INJURY IS A KNOWN, RARE RISK OF THE PROCEDURE, IDENTIFIED IN RISK DOCUMENTATION AND DEVICE LABELING. THIN/LEAN PATIENT ARE MORE SUSCEPTIBLE TO NERVE INJURY DUE TO REDUCED FAT LAYER. THE DEVICE USER MANUAL INCLUDES A CLINICAL WARNING AND PRECAUTION STATING, "PATIENTS WITH VERY LITTLE TO NO SUBCUTANEOUS FAT IN THE AXILLA ARE AT HIGHER RISK FOR NERVE-RELATED INJURIES, BECAUSE THERE IS A GREATER LIKELIHOOD THAT ONE OR MORE BRANCHES OF THE BRACHIAL PLEXUS MAY BE IN CLOSE PROXIMITY TO THE TARGET AREA". THIS INFORMATION IS COMMUNICATED IN USER TRAINING TO ENSURE APPROPRIATE ADMINISTRATION OF ANESTHESIA, PROVIDING AN ADEQUATE BUFFER BETWEEN THE SKIN SURFACE AND TARGETED TREATMENT AREA SHOULD THE CLINICIAN DETERMINE TREATMENT IS APPROPRIATE.