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 healthcare is issuing a safety alert in response to postmarketing reports received for the vascu-guard peripheral vascular patch for intraoperative or postoperative bleeding episodes which required additional clinical intervention. one report involved a case with a fatal outcome. at this point it is unknown whether there is any causal relationship between the device and the reported events.