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 product defect is leaking pressure tourniquet cuffs that went undetected during the manufacturing testing process. leaking devices may result in excessive blood loss requiring surgical or medical intervention or systemic leakage of local anesthetic during bier block requiring medical intervention.