WebMD Medical News
Laura J. Martin, MD
Dec. 21, 2011 -- The FDA has issued a new warning to consumers against the use of a massage device called the ShoulderFlex Massager, which was recalled earlier this year after it was blamed for causing at least one death.
According to the FDA, the distributor, King International, has gone out of business since the firm recalled the massagers on Aug. 31, 2011, and many stores that sell the device may not be aware it is dangerous.
Likewise, the FDA says many people who purchased the massager may be unaware that it is dangerous and that King International’s 800 number established for the recall has been out of service.
The ShoulderFlex Massager is a personal massage device sold in retail stores, via catalogs, and over the Internet. It is intended to provide a deep-tissue massage to the neck, shoulders, and back area, while lying down.
But the FDA says hair, clothing, and jewelry can become entangled in the device and cause serious injury or death from strangulation.
There have been reports of one death and one near-death, due to strangulation, associated with the use of the ShoulderFlex Massager.
“The ShoulderFlex Massager poses serious risks,” Steve Silverman of the FDA says in a news release.
Silverman, director of the FDA’s Office of Compliance in its Center for Devices and Radiological Health, says, “consumers should stop using this device, health care providers should not recommend it to their patients, and businesses should stop distributing and selling the device.”
The FDA says it discovered during a recent compliance audit that King International had gone out of business and that it had not followed through with recall procedures.
The FDA warning includes a recommendation to “safely dispose” of the massagers. It says the massage fingers should be removed and disposed of separately from the device, and the power supply disposed of separately, as well.
SOURCE:News release, FDA.
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