FDA Issues Warnings Pertaining to ShoulderFlex Massager
The United States Food and Drug Administration has issued warnings with regard to the use of ShoulderFlex Massager. The warming states that the massager can cause serious injuries like strangulation and even death in certain cases. The F.D.A has issued this warning in order to spread awareness amongst consumers about the health risks posed by this machine.
U.S. Consumer Product Safety Commission has reports of one death and one near- strangulation against ShoulderFlex massager. It is also believed that the manufacturer Kings International has few more instances recorded with it. FDA strictly mentioned that it does not endorse either the product or the company. The manufacturer along with the FDA initiated a recall of the machine in the year 2011.
Not only a recall was initiated, but the manufacturer also instructed all the users, retailers and catalog sellers to dispose of the parts of ShoulderFlex Massager, separately so that the same cannot be re-assembled and re- used. The manufacturer suggested that the power supply should be disposed off separately from the main massager unit and the same should be done with the fingers. The fingers of the massager unit should also be detached and thrown separately. The product was available in the United Sales through all the channels meant for sale namely stores, catalogs and online shopping. Kings International, the manufacturer is believed to have sold almost 12,000 machines in a span of 8 years i.e. from 2003 to 2011.
Though the massage machine was intended to be a stress reliever however it turned out to be a life threatening device. Loose clothing, open hair, necklaces and any other item could easily get stuck in the rolling head of the device, thereby causing high probability of strangulation and even death. The machine initially turned out to be a hit, however soon after there had been complications associated with the device.
FDA has stated that presently it is evaluating Kings International plan of recall of the device and in case the need arises it might even take additional action against the manufacturer.
In case you or your any of your loved ones have suffered after using ShoulderFlex Massager, then these adverse events can be reported to FDA. These adverse events will not only help the agency to identify the risks better, but would also help to understand the same in an explicit manner.
FDA always promotes all the healthcare professionals and the patients to report any kind of adverse events to the agency at the FDA’s MedWatch Safety Information and Adverse Event Reporting Program:
Complete and submit the report Online: www.fda.gov/MedWatch/report.htm