After receiving a report of one death and one near strangulation, the Food and Drug Administration (FDA) is advising people to stop using the ShoulderFlex Massager, a home-use massager which massages the back, shoulder and neck while the patient is lying down on a flat surface.
The ShoulderFlex Massager, which is distributed by King International, consists of a portable massager that is placed below the neck, a memory foam pillow, a controller, and a sleeve (machine washable). It has a bar which rotates - the bar has removable fingers which one can adjust, depending on the area and depth of massage desired.
The FDA is urging consumers and health care professionals to stop using this device because of the risk of strangulation or other serious and life-threatening injuries.
According to the FDA, the Consumer Product Safety Commission has received reports of one death and one near-strangulation caused by using the ShoulderFlex Massager. In these cases, a piece of clothing and a necklace got caught by the rotating part of the device while it was switched on.
The FDA says it knows of two other reports in which consumers' hair and clothing became caught in the ShoulderFlex Massager.
As jewelry, clothing and hair can get caught in the rotating device, the FDA says there is concern about the serious health risks, including death, associated with its use.
Since October 2003, King International has sold 11,934 units of the ShoulderFlex Massager through shops and online outlets.
The FDA is advising consumers:
- Not to use the ShoulderFlex Massager.
- When getting rid of the device, separate its parts beforehand so that they cannot be put together again and used - remove the massage fingers and the power supply and discard them separately.
The FDA says it is currently evaluating King International's plan to recall the ShoulderFlex Massager.
If you have had a problem with the ShoulderFlex Massager, or suspect you may have had a problem with it, file a voluntary report through MedWatch.
Written by Christian Nordqvist