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 have been reports that the localizing obturator is breaking before and during procedures at the glue joint between the body and the tip. these breakages in the field may result in harm to the patient and the need for additional intervention to remove the broken product from the patient.