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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Through post market surveillance edwards lifesciences has identified a potential health risk to patients regarding the use of fem-flex ii femoral arterial cannula sizes 8 10 and 12 french only. edwards has received one customer complaint regarding a released wire located at the tip area of the cannula which was identified prior to use. although the condition does not affect the functionality of the cannula there is potential patient safety risk if a protruding wire is not detected prior to use.