U.S. health regulators are warning consumers not to use the <"http://www.yourlawyer.com/practice_areas/defective_medical_devices">ShoulderFlex Massager because it poses a strangulation risk. According to an alert from the U.S. Food & Drug Administration (FDA), the ShoulderFlex Massager has been associated with at least one death and one near-strangulation.
The ShoulderFlex Massager, distributed by King International in Beaverton, Oregon, is a personal massage device designed for home use to provide deep tissue massage to the neck, shoulder and back while the user lies on a flat surface. It consists of a massage unit that sits beneath the neck, a handheld controller, a memory foam pillow and a machine-washable sleeve. The device contains a rotating bar with removable massage “fingers” that may be adjusted by the user to customize the massage area and depth.
King International has distributed 11,934 ShoulderFlex Massagers since Oct. 18, 2003, according to the FDA. The devices were sold at various stores and online retailers in the United States.
Both the fatality and near-strangulation associated with the ShoulderFlex Massager occurred when a necklace and clothing became caught in a piece of the device that rotates during use. The FDA said it is aware of two other reports of incidents involving clothing and hair becoming caught in the device.
According to the FDA, the ShoulderFlex Massager SHOULD NOT BE USED. The agency has also recommended that doctors advise their patients not to use this device.
Consumers have been asked to dispose of the ShoulderFlex Massager in such a way that device can’t be reassembled and used. As such, the power supply should be disposed of separately. The massage fingers should be removed, and also disposed of separately.
The FDA also said it is evaluating King International’s plan for recall of the ShoulderFlex Massager, which may lead to additional action or communication by the agency or King International.
Consumers who suspect a problem with the ShoulderFlex Massager are encouraged to file a voluntary report through MedWatch, the FDA Safety Information and Adverse Event Reporting program.