FDA Safety Notification: Ultraviolet Radiation Over-Exposure from Tootsie Tanner, a Portable Foot Tanning Device
Date Issued: August 20, 2010
Audience: Consumers, Tanning Salon Operators
Device: The Tootsie Tanner is a portable foot tanning device.
Summary of Problem:
The Tootsie Tanner, a portable foot tanning device, is labeled with an improper exposure schedule and has an inadequate timer control, each of which could lead to an overdose of ultraviolet radiation. The labeled exposure schedule indicates the product may be used for thirty minutes and the timer permits exposure up to thirty minutes, permitting exposure in excess of the maximum exposure time for this device. Based on FDA testing, maximum exposure time for this device is 20 minutes. The use of the recommended exposure schedule and/or the use of the timer could result in an overdose of ultraviolet radiation which may cause immediate and delayed eye and skin injuries. In addition, labeled warnings on the device about the need for protective eyewear are not sufficiently prominent.
The device was manufactured and distributed by IPCH, LLC. This company is now out of business. Therefore, the product will not be serviced, nor can it be replaced or refunded at the company’s expense. There were about 3,000 units sold.
Although FDA has received no adverse event reports to date, the agency is concerned about the risk of eye and skin injuries from an overdose of ultraviolet radiation.
The FDA would like tanning salon owners, facilities with tanning services and purchasers of Tootsie Tanners to be aware that these devices should not be used because use in accordance with their labeling can result in excessive exposure to radiation. The FDA recommends that users of this device, which include tanning salon owners and operators, stop using this device, remove the lamps and safely discard all components of the device according to local environmental protection standards.
Report Problems to FDA:
Prompt reporting of adverse events can help FDA identify and better understand the risks associated with medical devices. If you suspect a problem with the Tootsie Tanner, we encourage you to file a voluntary report through MedWatch, the FDA Safety Information and Adverse Event Reporting program.
If you have questions about this communication, please contact the Division of Small Manufacturers, International and Consumer Assistance (DSMICA) at DSMICA@FDA.HHS.GOV or 800-638-2041.
This document reflects FDA’s current analysis of available information, in keeping with our commitment to inform the public about ongoing safety reviews of medical devices.