VIOS LC AEROSOL DELIV SYST

Description of Event or Problem

INDICATION - CHRONIC OBSTRUCTIVE PULMONARY DISEASE, UNSPECIFIED PT AND PATIENT'S CAREGIVER, STATES AND THE SUSPENSION IS TO WATERY COMPARED TO EXPECTED COLOR: CLOUDY AND YELLOW TO PALE YELLOW IN COLOR AFTER SHAKING AS PREVIOUSLY. PT ALREADY USED HALF OF THE BOX BUT DIDN'T GET A CHANCE TO REPORT THIS. (B)(6) SAID THAT VIOS NEBULIZER DOESN'T WORK ANYMORE AS WELL BUT HE HAS ANOTHER NEW ONE ON HANDS, UNKNOWN IF PATIENT MISSED A DOSE; NO ADVERSE EVENTS REPORTED; UNKNOWN IF DEVICE AVAILABLE FOR RETURN. UNKNOWN IF MD IS AWARE. NO FURTHER INFORMATION PROVIDED.