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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Arrow international has issued this voluntary field corrective action (fca) because the contraindication for patients with known hypersensitivity to chlorhexidine silver sulfadiazine and/or sulfa drugs was not printed on the lidstock. the contraindication statement is still contained in the instructions for use/ifu.