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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Edwards lifesciences has identified a potential safety risk which may occur during the use of the intraclude intra-aortic occlusion device (icf100) used in cardiopulmonary bypass surgery. edwards has received a limited number of reports regarding device damage on the strain relief near the hub area. some of the reports have also indicated blood leakage in this area. when damage exists blood loss can occur because blood can fill the device between the lumen shaft and the strain rerlief and leak from the area. no injuries or blood transfusions have been reported. in a worst case scenario with no mitigation blood loss can occur during use of the device.