Australia Issues Warning on American Medical Systems' Urinary Control Systems
Australian healthcare regulators warn that certain lots of urinary controls devices made by American Medical Systems may cause patients harm.
Australian healthcare regulators issues a safety advisory late last month on certain lots of American Medical Systems' (NSDQ:AMMD) AMS 800 urinary control systems, warning that the devices were released on the market on the market without meeting the company's product release criteria.
The AMS 800 devices are part of implantable artificial urinary control systems, for use in patients with severe incontinence. The device operates via a manual control pump that uses pressure to open and close the urethra.