OPTICHAMBER DIAMOND

Description of Event or Problem

THE MANUFACTURER WAS CONTACTED IN REFERENCE TO THE OPTI CHAMBER DEVICE. THE USER ALLEGES THE DEVICE WAS NOT HOLDING THE MEDICATION AND THE PATIENT DID NOT RECEIVE THE PROPER DOSE OF MEDICATION. THERE IS NO ALLEGATION OF SERIOUS OR PERMANENT HARM OR INJURY. NO MEDICAL INTERVENTION WAS REQUIRED BY THE PATIENT. THE MANUFACTURER'S INVESTIGATION IS ONGOING. A FOLLOW-UP REPORT WILL BE SUBMITTED WHEN THE MANUFACTURER'S INVESTIGATION IS COMPLETE.