Patients undergoing surgery do not count on possibly being injured by medical devices. However, the Stryker Waste Management System has caused some problems for some patients and possibly one death as a result of the allegedly faulty device.
As early as August 2010, the U. S. Food and Drug Administration received patient reports of problems around the Stryker Waste Management System, also called the Neptune Waste Management System.
The Stryker Waste Management System is a medical device used to dispose of waste products during surgery such as fluids and other waste products in operating rooms and surgical facilities.
This high suction vacuum device has been linked to numerous injuries and up to two deaths, according to the FDA.
The FDA notes that it is especially concerned that hospital staff may not be correctly trained to use the Neptune Stryker Waste Management System devices, and that because of this, it is critical that hospitals take note of Stryker’s updated certificate program to use the devices.
If a Stryker Waste Management System is used incorrectly, the high-flow, high-suction vacuum device and initiate hemorrhaging as well as soft tissue, organ and muscle injury. This can lead to severe problems as well as death.
The FDA reports that in one fatal case, the Neptune system was connected to a chest tube of a patient undergoing pneumonectomy, a surgical removal of a lung or part of a lung. In this unfortunate case, the suction pulled the heart muscle from its left position in the chest which caused a tear in the aorta.
Another report claims that one patient lost enough blood after a Stryker Waste Management System was used that the patient’s blood pressure and pulse stopped. This patient needed resuscitation and had severe health problems leading forward.
Stryker began to initiate a recall of their Neptune 1 and Neptune 2 devices and then issued the new instructions for use to hospitals in 2012. In October 2012, Stryker issued a Class I Recall Notice. This is only issued for medical drugs or devices that cause serious injury or death.
This recall notified hospitals and other surgical facilities that they needed to stop using the Stryker Waste Management System if possible and then put warning labels on the devices already in use.
Critics claim that the Stryker Waste Management System devices did not go through proper FDA approval.
Stryker has made it public that they did receive a warning letter from the FDA stating that they didn’t go through the proper channels for marketing the Neptune devices and that they didn’t notify the FDA about the original device recall.
The FDA said that they were “partially concerned” about new Stryker Waste Management System injuries because hospitals needed to ensure that all users of the device are properly trained.
If you or someone you love have been injured by a Stryker Waste Management System, you may be entitled to legal compensation.
Do YOU have a legal claim? Fill out the form on this page now for a free, immediate, and confidential case evaluation. The hip implant attorneys who work with Top Class Actions will contact you if you qualify to let you know if an individual lawsuit or class action lawsuit is best for you. [In general, metal hip implant lawsuits are filed individually by each plaintiff and are not class actions.] Hurry — statutes of limitations may apply.
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