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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It was discovered that a patient received grade 3 dermatitis in the contralateral axilla. it was determined the user did not include the contralateral axilla during evaluation of the treatment plan. as a result dose to this region was unaccounted for and ultimately delivered leading to grade 3 dermatitis.