MICROMIST NEBULIZER

Description of Event or Problem

(B)(6) / I AM REPORTING A SERIOUS SAFETY, CONTAMINATION, LABELING, AND POSSIBLE MISBRANDING CONCERN INVOLVING A DEVICE SOLD AS THE ¿MICROMIST/MICROMIST NEBULIZER¿ FROM GETMICROMIST.COM. I PURCHASED TWO UNITS. ONE DEVICE ARRIVED WET INSIDE BEFORE ANY USE, AS THOUGH IT MAY HAVE BEEN PREVIOUSLY USED, CONTAMINATED, IMPROPERLY STORED, OR INADEQUATELY MANUFACTURED/PACKAGED. THE SECOND DEVICE APPEARS TO HAVE MOLD OR MOLD-LIKE CONTAMINATION INSIDE THE GASKET AREA AT THE TOP OF THE MOUTHPIECE. THIS IS A SIGNIFICANT RESPIRATORY SAFETY CONCERN BECAUSE THE DEVICE IS SOLD AS A NEBULIZER/ATOMIZER USED TO AEROSOLIZE LIQUID FOR INHALATION. IF CONTAMINATED, PREVIOUSLY USED, OR IMPROPERLY STORED DEVICES ARE BEING SHIPPED TO CONSUMERS, PATIENTS MAY INHALE MOLD, BACTERIA, RESIDUE, OR OTHER UNKNOWN CONTAMINANTS DIRECTLY INTO THEIR AIRWAYS. THE LIKELY USERS OF THIS PRODUCT INCLUDE PEOPLE WITH ASTHMA, COPD, RESPIRATORY INFECTIONS, DISABILITIES, IMMUNE COMPROMISE, CHILDREN, ELDERLY PATIENTS, AND OTHERS WITH VULNERABLE RESPIRATORY HEALTH. THE PRODUCT LABELING IS ALSO HIGHLY INCONSISTENT AND CONCERNING. THE BOX IS BRANDED WITH A ¿MICROMIST¿ STICKER PLACED OVER PACKAGING THAT OTHERWISE SAYS ¿NEBULIZER.¿ THE FRONT OF THE BOX SAYS ¿NEBULIZER HSK-W005.¿ ANOTHER SIDE LISTS THE PRODUCT NAME AS ¿VOLTAGE NETWORK TYPE ATOMIZER.¿ THE INCLUDED INSERT IDENTIFIES IT AS ¿HOUSEHOLD ATOMIZER,¿ LISTS PATENT NUMBER (B)(4), AND NAMES (B)(4). THE INSERT STATES THE PRODUCT PURPOSE IS ¿FOR PATIENT¿S MEDICATION ATOMIZING¿ AND REPEATEDLY REFERENCES MEDICATION/PATIENT USE AND INSTRUCTIONS FOR NEBULIZED OR ATOMIZED MEDICATIONS. HOWEVER, THE SAME INSERT ALSO STATES, ¿THIS PRODUCT BELONGS TO HOME USE AND IS NOT FOR MEDICAL USE.¿ THESE STATEMENTS DIRECTLY CONFLICT. THE SAFETY INFORMATION ALSO APPEARS INACCURATE. THE INSERT STATES IN MULTIPLE PLACES THAT THERE IS NO BATTERY INSIDE THE DEVICE, BUT THE BOX STATES IT CONTAINS A LITHIUM-ION BATTERY, AND THE PRODUCT IS MARKETED AS BATTERY-POWERED. THE INSERT IMAGES MATCH THE DEVICE RECEIVED, SO THIS APPEARS TO BE THE INTENDED DOCUMENTATION. THE COMPANY HAS NOT RESPONDED TO CUSTOMER INQUIRIES IN A TIMELY, GOOD-FAITH MANNER, AND I HAVE SEEN OTHER CONSUMER REVIEWS DESCRIBING SIMILAR PRODUCT AND BUSINESS CONCERNS. I AM REQUESTING FDA REVIEW OF THIS PRODUCT¿S CONTAMINATION RISK, LABELING, MEDICAL-USE CLAIMS, BATTERY/SAFETY REPRESENTATIONS, IMPORT/MANUFACTURING SOURCE, AND WHETHER IT IS LAWFULLY MARKETED AS A NEBULIZER/MEDICAL DEVICE IN THE UNITED STATES. I BELIEVE THIS PRODUCT MAY POSE A SERIOUS RISK TO CONSUMERS WHO DEPEND ON SAFE NEBULIZED MEDICATION DELIVERY. THE INSTRUCTIONS REPEATEDLY REFERENCE MEDICATION USE AND PATIENT USE. THE STATED PURPOSE IS ¿FOR PATIENT¿S MEDICATION ATOMIZING,¿ AND THE LITERATURE PROVIDES DIRECTIONS FOR TAKING NEBULIZED/ATOMIZED MEDICATION THROUGH THE DEVICE. HOWEVER, THE SAME LITERATURE ALSO STATES, ¿THIS PRODUCT BELONGS TO HOME USE AND IS NOT FOR MEDICAL USE.¿ THESE STATEMENTS ARE CONTRADICTORY. A PRODUCT CANNOT BE SAFELY AND TRANSPARENTLY MARKETED TO CONSUMERS AS A NEBULIZER FOR PATIENT MEDICATION ATOMIZATION WHILE SIMULTANEOUSLY DISCLAIMING THAT IT IS NOT FOR MEDICAL USE. THE INSERT ALSO CONTAINS THE PHRASE, ¿PLEASE USE IT WITHOUT WORRY ABOUT THE SAFETY HAZARDS,¿ WHICH IS CONCERNING IN CONTEXT BECAUSE THE DEVICE ARRIVED WET/CONTAMINATED AND THE LABELING CONTAINS CONTRADICTORY SAFETY AND TECHNICAL INFORMATION. LACKS UNIT ID AND MANUFACTURING LOT NUMBERS/CODES/SERIAL NUMBERS. / PRODUCT DETAILS: ¿NEBULIZER.¿ ¿NEBULIZER HSK-W005.¿ ANOTHER SIDE LISTS THE PRODUCT NAME AS ¿VOLTAGE NETWORK TYPE ATOMIZER.¿ THE INCLUDED INSERT IDENTIFIES IT ¿HOUSEHOLD ATOMIZER,¿ LISTS PATENT NUMBER (B)(4), AND NAMES (B)(4). PT: 4582. DEVICE: 1120, 2911, 3007. REF: MW5190248. THIS REPORT CAPTURES MICROMIST NEBULIZER #1.