Pharmacy Daily | Urinary issues

THE Therapeutic Goods Administration is advising Australian health professionals and consumers that selected lots of AMS 800 Control Pumps may not function as intended by the manufacturer, American Medical Systems Inc (AMS). AMS 800 Control Pumps are used in artificial urinary control systems, which are implanted in patients with moderate to severe incontinence to simulate normal urinary function. Investigations undertaken in response to customer complaints have found that selected lots of two models of control pumps supplied in Australia were released despite not fully meeting the manufacturer's product release criteria. The item numbers for the affected models are: 72400098 and 72404127. All affected stock has been removed from the field. Healthcare professionals that have patients with symptoms that suggest their artificial urinary control system is not functioning as intended should be referred to a urologist, preferably the implanting urologist. For more information see www.tga.gov.au.

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