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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A discrepancy in subject device product labeling exists. the programmed software settings were determined to be higher than those required for the model of handpiece deployed on patients. an examination of subject device lightsheer desire laser system labeling found the physician recommended treatment settings did not match the settings identified by the subject device software when specific patient skin types and hair color were selected. an inexperienced device operator would not be aware the treatment settings identified by the system software are incorrect.