Canadian data is current through March 2018. All of the data comes from Health Canada, except for the categories Manufacturer Parent Company and Product Classification.
The Parent Company and the Product Classification were added by ICIJ.
The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of recall data from the U.S. and Canada.
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Baxter has provided customers with an important product information notice regarding floseal hemostatic matrix. an update has been added to the precautionary statement of the instructions for use reminding users of the potential risk of inadvertent intravascular uptake of flowable hemostatic material particularly during surgical procedures which require exposure and opening of large or multiple veins (venous plexi). this may result in life-threatening thromboembolic events either at the time of application or in the post-operative period. patient positioning during surgery can result in low or negative venous pressure leading to hemostat introduction into the patient's blood stream.