MAUDE Adverse Event Report: SECURA, INC. SECURA O3 FACIAL AND HAIR STEAMER; HUMIDIFER

Device Problem Gas Output Problem (1266)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 01/30/2015

Event Type  No Answer Provided  

Event Description

California air resources board (arb) staff recently measured ozone emissions from 17 consumer products and home appliances and published a journal article on the results, which can be found at http://onlinelibrary.Wiley.Com/doi/10.1111/ina.12307/pdf.We found that five products in three categories produced ozone at levels that may result in adverse health effects.Ozone is a reactive gas comprised of three oxygen atoms.While ozone high up in the atmosphere protects us from the sun's harmful rays, at ground level, ozone an cause adverse health effects such as coughing, chest tightness and shortness of breath.Exposure to ozone may both induce and worsen asthma symptoms and worsen lung disease; it might also increase the risk of premature death.Some consumer products and home appliances are designed to emit ozone either intentionally, or as a by-product of their functions.This study measured ozone emissions and impacts on indoor ozone levels and associated exposures from 17 consumer products and home appliances that could emit ozone either intentionally or as a by-product of their functions.Nine products were found to emit measurable ozone, one up to 6,230 ppb at a distance of 5 cm (2 inches).Five products in three categories produced ozone at levels that may result in potential health effects, including a residential ozone laundry water treatment appliance, two fruit and vegetable washers, and two facial steamers.Use of some of these products increased ozone concentrations in a small room to concentrations that exceeded the level of 1-hr california ambient air quality standard (caaqs) for outdoor ozone (0.09 parts per million [ppm]).The greatest increase of room ozone concentrations during typical use of the products resulted from use of the laundry water treatment system.During one wash cycle, this product increased the room ozone concentration by an average of 0.11 ppm.Due to users' close proximity to this product, the concentration of ozone that users might actually be exposed to (the personal exposure concentration) can be even higher than the room concentrations measured.During one wash cycle, users of the laundry water treatment system may be exposed to an average of 0.42 ppm ozone potentially for 1 hour.This level of exposure is equivalent to about one-quarter to one-half of the ozone that a typical california resident may be exposed to in one day.For some products, one use does not increase the room ozone concentrations markedly, but repeated use can result in high personal exposure concentrations for the use.For example, when a fruit and vegetable washer was used for three continuous wash cycles with reused water, the average personal exposure concentration was 2.55 pp, over 28 times higher than the level of the 1-hr caaqs.For the remaining products tested, their average ozone emissions were low, but surprisingly high peaks were commonly observed.When using a facial steamer with an ozone-emitting ultraviolet (uv) bulb, for example, peak ozone levels as high as 1.1 ppm were reached.Although their market share is unknown, these products can easily be obtained due to their low unit price and widespread advertising via the internet and television.Thus, the exposures associated with the use of such products may be widespread.However, none of these products are regulated for their ozone emissions, which is a critical gap in consumer protection.Actions should be taken to protect consumers from potential exposures to high levels of ozone from these products.The five products emitting ozone at levels that may result in potential health effects include: o3 pure eco laundry system; this is a device that connects to the water inlet of a washing machine.There is an on-board ozone generator that generates and diffuses ozone into water.Manufacturer: kel technologies/o3-pure, (b)(4); model: o3-pure-ls-lf; available at (b)(4); o3 pure elite 50 kt fruit & vegetable washer; this is a washer for fruit and vegetables that has an on-board ozone generator diffusing ozone into water.Manufacturer: kel technologies/o3-pure, (b)(4); model: elite50kt; available at (b)(4); engreener hand-held ultrasonic fruit & vegetable washer; this is a handheld washer for fruit and vegetables that immerses in water and generates ozone into water.Manufacturer: dyne electronics, inc., (b)(4); model: ye-8000; available at (b)(4); secura o3 facial and hair steamer: this is a steamer that has an uv bulb.The uv bulb generates ozone that comes out of the steam outlet.Manufacturer: secura, inc.(b)(4), usa; model: s-192; available at (b)(4); table top mini facial hot steamer: this is a steamer that has an uv bulb.The uv bulb generates ozone that comes out of the steam outlet.Manufacturer: unknown; model: unknown; available at (b)(4).

• Brand Name: SECURA O3 FACIAL AND HAIR STEAMER
• Type of Device: HUMIDIFER
• Manufacturer (Section D): SECURA, INC.
• MDR Report Key: 8074764
• MDR Text Key: 128202035
• Report Number: MW5081316
• Device Sequence Number: 1
• Product Code: KFZ
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 01/03/2017
• 2 Devices were Involved in the Event: 1 2

1 Patient was Involved in the Event

• Date FDA Received: 11/14/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1