MIRADRY SYSTEM

Additional Manufacturer Narrative

TREATMENT DATA REVIEW SHOWED NO SYSTEM MALFUNCTIONS. 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. INFECTION IS A RARE KNOWN RISK OF THE MIRADRY TREATMENT, HOWEVER, INCREASED RISK OF INJURY ASSOCIATED WITH MULTIPLE TREATMENTS IN THE SAME AREA WERE DETERMINED TO BE A CONTRIBUTING FACTOR AND/OR CAUSE OF THIS EVENT. THE DISTRIBUTOR HAS BEEN DIRECTED TO RETRAIN THE USER ON BOTH PROPER EXECUTION AND AFTERCARE TO PREVENT RECURRENCE. THERE HAVE BEEN NO OTHER SIMILAR OR RELATED REPORTS FROM THIS USER OR TRENDS INDICATING ADDITIONAL ACTION SHOULD BE TAKEN AT THIS TIME. CONTINUED MONITORING AND FOLLOW UP, INCLUDING TRACKING AND TRENDING OF THIS AND OTHER POTENTIALLY RELATED EVENTS IS BEING PERFORMED UNDER ROUTINE QUALITY SYSTEM PROCESSES. FURTHER ACTION INCLUDING INVESTIGATION WITH CONSIDERATION AND EXECUTION OF CORRECTION(S), CORRECTIVE ACTION, AND/OR PREVENTIVE ACTION WILL BE TAKEN IF AND WHEN NECESSARY.

Description of Event or Problem

DISTRIBUTOR REPORTED INFORMATION FROM CLINIC REGARDING PATIENT WITH SUSPECTED INFECTION (CELLULITIS). THE TREATING PHYSICIAN PROPHYLACTICALLY PRESCRIBED 3 DAYS OF LOXONIN FOR PAIN MANAGEMENT AND 5 DAYS OF FOSFOMYCIN FOR INFECTION PREVENTION. 16 DAYS POST TREATMENT, SIGNS OF INFECTION WERE OBSERVED WITH 5 DAYS OF CRAVIT AND CALONAL PRESCRIBED. SYMPTOMS APPEARED UNCHANGED 7 WEEKS LATER, THUS THE PHYSICIAN ADMINISTERED INTRAVENOUS CEFAZOLIN. SYMPTOMS WERE RESOLVING AT THE TIME OF THE REPORT.