FDA Adverse Event Malfunction Summary report: N

MYPURMIST

MDR report key: 3704976 · Received March 24, 2014

Report

Report Number
MW5035235
Event Type
Malfunction
Date Received
March 24, 2014
Date of Event
November 1, 2013
Report Date
March 22, 2014
Manufacturer
VAPORE, LLC
Product Code
KFZ
Product Problem
Yes
Report Source
Voluntary report
Reporter Location
FL, US
Reporter Occupation
PATIENT FAMILY MEMBER OR FRIEND

Narratives

Description of Event or Problem · 1

I AM REPORTING A HANDHELD STEAM INHALER BEING MARKETED ON TV AND ON THE INTERNET BY VAPORE LLC, KNOWN AS MYPURMIST AND MYPURFILL WHICH WE PURCHASED AND RETURNED AFTER THEY ALL MALFUNCTION (NOW 5 UNITS... 3 PURCHASED AT (B)(6), 1 RETURNED TO MANUFACTURER AND 1 STILL PENDING AT MANUFACTURER). THESE UNITS HAVE A MAJOR OPERATING DEFECT/FLAW (AFTER 1 USE FOR TWO WEEKS OF 3X DAILY USAGE, THE BLUE LIGHTS FREEZE AND RED LIGHT AND FAN GO ON AND UNIT DOES NOT OPERATE OR IT BEGINS TO STEAM FOR 20 MINUTES, NEXT TIME IS REDUCED TO 9 MINUTES THEN OPERATES FOR 1 MINUTE THEN RED LIGHT AND FAN GO ON AND STOPS.) VAPORE LLC NOTIFIED US THE CAUSE OF THE MALFUNCTION WAS A SUSPICIOUS BROWN SUBSTANCE FOUND ON THE APPLIANCE FILTER (CLAIM WAS ALBUTEROL, AND THEN THEY CLAIMED ANY SUBSTANCE OTHER THAN DISTILLED WATER IS CAUSING BROWN SUBSTANCE). THIS CONSUMER HAS ONLY USED DISTILLED WATER IN ALL OF THE MYPURMIST AND HAS NOT VIOLATED ANY INSTRUCTIONS FOR THEIR WARRANTY TO APPLY. VAPORE LLC REFUSES TO DISCLOSE THIS POTENTIALLY UNSAFE BYPRODUCT WHICH IS CAUSING THE MALFUNCTION BUT WILL NOW ONLY REFUND OUR MONEY IF WE GO AWAY QUIETLY AND NOT PURCHASE THEIR PRODUCT AGAIN. MY (B)(6) OLD MOTHER SUFFERS FROM BRONCHIECTASIS, SIADH, AND TACHYCARDIA FROM ALLERGIC REACTIONS TO MEDICATIONS. I AM VERY CONCERNED ABOUT THE NATURE OF THIS BROWN SUBSTANCE SINCE WE ARE DEFINITELY NOT THE CAUSE OF THIS SUBSTANCE OR THE MALFUNCTION, I ASK THE FDA TO INVESTIGATE THIS DEFECT AND SUBSTANCE. THIS UNIT IS BEING ASSEMBLED IN (B)(4) AND WE ARE CONCERNED THAT DESPITE THE NUMEROUS U.S PATENTS THIS PRODUCT HAS STATED ON THE BOX THAT SOMEHOW THIS DEFECT AND SUSPICIOUS BROWN BYPRODUCT IS BEING ALLOWED.

Devices

Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
173566 MYPURMIST HUMIDIFIER KFZ VAPORE, LLC CDS084-A240

Patients

Seq Age Sex Outcome Treatment
1 78 YR