FDA is aware of strangulations in these systems and advises to stop using ShoulderFlex.
Distribution is said to be USA.
Regarding possible dealing via Internet, it can not be excluded that some of these systems may also be used in Europe and Germany.
Thus, BfArM forwards this information with reference to the FDA’s advice:
According to the German medical devices act, supervision of users and facilities is a matter of the Federal Competent Authorities.
In case of questions please contact:
Federal Institute for Drugs and Medical Devices
Medical Devices Division
Kurt-Georg-Kiesinger-Allee 3
53175 Bonn
Telephone: +49 (0)228 99 307-5306 (active and in vitro diagnostic medical devices)
Facsimile: +49 (0)228 99 307-5300
E-Mail:
md-vigilance@bfarm.de
