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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Size 16 french self cath catheters were mislabelled. although the catheters were properly labelled as 16fr on their primary packaging the retail box containing the catheters was labelled 10fr. this could lead to an individual using a catheter larger than what is appropriate for his/her anatomy.