LIVING AIR *

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2002-03-06 for LIVING AIR * manufactured by Alpine Industries, Inc..

Event Text Entries

[271782] The complainant says co was deceptive in presenting their air purifier model #xl-15s. The pt has leukemia. The co rep claimed that the purifier would clean the air, make it like "mountain air", create ozone, make the environment healthier and the family healthier; and the machine "acts like lightning" in purifying the air. Complainant said the word cure wasn't used. The rep knew pt had leukemia. Complainant stated that the rep brought a machine that was too big for the area. She put it in pt's bedroom and set dial for 500', and their bedroom is around 250'. She also had air blowing right on pt's bed. She said the machine had no instruction manual. The rep just left leaflets for this and other merchandise. The literature said the purifier was regulated by fda. The complainant found out it can cause ozone poisoning, oxygen poisoning and sun poisoning. Rep said could cause headaches, but they would go away. She said their family member has a small machine and she read a warning which said to not put in the face of a person or pet. The complainant stated that the device was to produce ozone gas, and there was a smokey odor in the room after using for a while. Consumer said the pt's condition had improved, but after using the purifier for about 2 days, pt became very ill with fever and headaches and had to be admitted to the hosp. When complainant complained to rep, she said she would pick up the machine and refund money, but complainant didn't want to release it until complainant found out more about it. Complainant spoke with supv from co. He said the purifier isn't fda approved. Complainant said supv stated that it could cause headaches, vomiting, tiredness, damage to lungs, eyes, ears, and nose. He said it should have been centralized, such as in a hallway and not in a room. Complainant said the rep should have informed them about possible side effects. Complainant said that also spoke with another rep in the co who said the purifier could cause plastic flowers to "decay".
Patient Sequence No: 1, Text Type: D, B5

MAUDE Entry Details

• Report Number: MW4003230
• MDR Report Key: 384311
• Date Received: 2002-03-06
• Date of Report: 2002-03-06
• Date of Event: 2002-02-23
• Date Added to Maude: 2002-03-27
• Event Key: 0
• Report Source Code: Voluntary report
• Manufacturer Link: N
• Number of Patients in Event: 0
• Adverse Event Flag: 3
• Product Problem Flag: 3
• Reprocessed and Reused Flag: 0
• Reporter Occupation: PATIENT FAMILY MEMBER OR FRIEND
• Health Professional: 3
• Initial Report to FDA: 0
• Report to FDA: 0
• Event Location: 3
• Single Use: 0
• Previous Use Code: 0
• Event Type: 3
• Type of Report: 3

Device Details

• Brand Name: LIVING AIR
• Generic Name: AIR PURIFIER
• Product Code: FRF
• Date Received: 2002-03-06
• Model Number: *
• Catalog Number: *
• Lot Number: *
• ID Number: *
• Device Availability: *
• Implant Flag: N
• Date Removed: *
• Device Sequence No: 1
• Device Event Key: 373363
• Manufacturer: ALPINE INDUSTRIES, INC.
• Manufacturer Address: 310 T ELMER COX DR GREENEVILLE TN 37745 US

Patients

Patient Number	Treatment	Outcome	Date
1	0		2002-03-06