MIRADRY SYSTEM

Additional Manufacturer Narrative

TREATMENT DATA SHOWED THE DEVICE WORKING AS INTENDED WITH NO PERFORMANCE ISSUES THAT WOULD IMPACT PATIENT SAFETY. THE REPORTED BURN LOCATION WAS INCONSISTENT WITH THE RECORDED TREATMENT LOCATIONS. A TEMPORARY TATTOO TO GUIDE THE USER IN DEVICE PLACEMENT TO ENSURE PATIENT SAFETY WAS NOT USED. 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

PATIENT COMPLAINED OF PAIN DURING TREATMENT PERFORMED (B)(6) 2025. ADDITIONAL ANESTHESIA WAS ADMINISTERED AND THE PROCEDURE CONTINUED. PATIENT RETURNED TO THE CLINIC 14 DAYS LATER WITH PERIPHERAL ERYTHEMA WITHOUT VISIBLE PURULENT EXUDATE, SEVERE PAIN UPON PALPATION, AND PERILESIONAL LESIONS WITH ASSOCIATED LYMPH NODE INVOLVEMENT IN THE LEFT AXILLA. DIAGNOSIS OF SECOND-DEGREE BURN TREATED WITH THE FOLLOWING; -SYSTEMIC ANTIBIOTIC: CEFADROXIL 500 MG EVERY 12 HOURS FOR 10 DAYS. -TOPICAL TREATMENT: MUPIROCIN + CICALFATE. -DRESSING CHANGES EVERY 48 HOURS.