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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The provided label does not reflect the current legal manufacturer and when applicable the current ce mark. the product label incorrectly lists tenet medical engineering as the legal manufacturer with tenet ce mark when applicable as opposed to smith & nephew. the labeling error is not obvious to the user.