MIRADRY SYSTEM

Additional Manufacturer Narrative

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. A REVIEW OF THE TREATMENT DATA CONFIRMED THE SYSTEM WAS OPERATING WITHIN NORMAL SPECIFICATIONS. DATA SHOWED 8 ADDITIONAL (DUPLICATE) TREATMENTS ON THE LEFT AXILLA. ERROR CODE A16 INDICATING HIGH TEMPERATURE MEASUREMENTS WERE ASSOCIATED WITH THE 8 DUPLICATE TREATMENT LOCATIONS. A PHOTO OF THE PATIENT¿S AXILLA SHOWS TREATMENT WAS PERFORMED OUTSIDE OF THE HAIR BEARING AREA. INSTRUCTIONS TO AVOID DUPLICATE (MULTIPLE) PLACEMENTS AND TREATMENT OUTSIDE THE HAIR BEARING AREA ARE INCLUDED IN THE INSTRUCTIONS FOR USE AND USER TRAINING. SECTION E: THIS EVENT WAS REPORTED BY A FOREIGN DISTRIBUTOR. INITIAL REPORTER INFORMATION WAS NOT INCLUDED IN THE REPORT AND HAS BEEN REQUESTED. A FOLLOW UP REPORT WILL BE SUBMITTED IF FURTHER INFORMATION IS RECEIVED.

Description of Event or Problem

CLINIC NOTED ERROR CODES APPEARING DURING TREATMENT WITH A BURN IN THE PATIENT'S LEFT AXILLA WITH TWO TO THREE SUPERFICIAL SPOTS THAT FELT HARD AND ROUGH. ON EXAMINATION WITH INDEX FINGER PRESSURE, A PATCH OF SKIN WAS OBSERVED TO HAVE BECOME UNUSUALLY HARD. FOLLOW UP INFORMATION RECEIVED 10/07/2025 INDICATED THE BURN AREAS SHOW ERYTHEMA WITH YELLOWISH SLOUGH AND INFLAMMATION. THE CLINIC SUSPECTED AXILLARY SOFT TISSUE INFECTION WITH POSSIBLE UNDERMINING ABSCESS. THE PATIENT WAS BEING TREATED WITH ANTIBIOTICS.