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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There is a possibility that a lay user obtains a body temperature value of a febrile patient that is lower than actual just missing the fever threshold. the lay user might not recognize a false negative fever measurement as inaccurate and base the decision not to seek help or not to treat solely on the reading of the device ignoring other possible symptoms of disease. this may lead to delayed treatment which might contribute to an injury or aggravation of the underlying disease. instructions for use instruct users of the ear thermometer sch740 on the way to take measurements including how to direct the device and keep the sensor tip clean which are most crucial aspects for obtaining a proper temperature reading. the users are cautioned that the values are for reference only and not a substitute for professional advice.