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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A detailed investigation points to a unique use case involving a single canadian customer using non-approved smiths medical pouches with the cadd? blue-striped administration set. use of non-approved accessories as indicated in labeling may adversely affect pump operation. smiths medical has decided to proceed with sending communication to notify all canadian customers who have purchased the cadd blue-striped administration set. the content of the fsn provides more information to the customer / user when using the administration set. fsn emphasizes the correct use of the product and how to avoid strain relief which in turn prevents leakage.