ENVIRACAIRE IFD AIR PURIFIER 60000

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2008-08-25 for ENVIRACAIRE IFD AIR PURIFIER 60000 manufactured by Kaz, Inc..

Event Text Entries

[930850] I purch. Enviracaire ifd air purifier made by kaz, inc in 2006. Product advertises that it filters cigarette smoke. I have lyme disease. In 2007, i began smelling weird chemical odor when returning to my apt. , but could not figure out what it was. I kept cleaning filter in unit, but odor kept getting stronger. In early 2008, i noticed brown scum all over pictures, etc. In bedroom, where i don't smoke, and contacted kaz, inc. I was informed that the unit doesn't actually filter smoke and that smoke ruins the filter. They only offered to replace filter once free of charge and i had to mail old filter in to them-even though unit was useless to me then. Upon return from mailing filter, chemical odor had died down a little. I then realized the unit was putting that odor out. I washed walls, nic-nacs, etc. & left windows open for couple of months airing the place out. I had to go out of town to doctor end of 2008 and was gone for 9 days. My apt. Was shut up and i turned a/c unit off. Upon return, the odor was so strong, you could smell it outside with the door barely cracked open. My eyes were on fire for 4 days and i couldn't stand being in there. My chest had already started hurting before i even left town. I then realized the odor was not going away and had absorbed into everything in there. I contacted kaz, inc. Again. They wanted me to mail unit in to them, but i refused as everyone had advised me against doing that. I have since had an inspector out and had to pay out of pocket for that. Kaz, inc. Is refusing to pay for anything and only offered to swap the unit out for me. I still have this smell in my home as several items which will run into expense need to be replaced or cleaned in order to get rid of it. I'm also still breathing this. I've already had to go to doctor with lungs hurting. I have contacted every government agency i can find trying to get some help with this matter. I am on disability and cannot afford to have to replace everything myself. Please help me with this matter if you can. Thank you. Dates of use: 2006 - 2008. Diagnosis or reason for use: filter cig. Smoke, other pollutants.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report NumberMW5008086
MDR Report Key1135265
Date Received2008-08-25
Date of Report2008-08-25
Date of Event2008-04-01
Date Added to Maude2008-09-03
Event Key0
Report Source CodeVoluntary report
Manufacturer LinkN
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag0
Reporter OccupationPATIENT
Health Professional3
Initial Report to FDA3
Report to FDA0
Event Location0
Single Use0
Previous Use Code0
Event Type3
Type of Report3

Device Details

Brand NameENVIRACAIRE IFD AIR PURIFIER
Generic NameAIR PURIFIER
Product CodeFRF
Date Received2008-08-25
Model Number60000
OperatorOTHER
Device AvailabilityY
Implant FlagN
Date RemovedB
Device Sequence No1
Device Event Key1148917
ManufacturerKAZ, INC.
Manufacturer AddressSOUTHBORO MA US


Patients

Patient NumberTreatmentOutcomeDate
101. Deathisabilit 2008-08-25

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