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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Sam medical is voluntarily recalling the sam junctional tourniquet (sjt) auxiliary (accessory) strap which is intended for use in the control of difficult bleeds in the axilla area. only the auxiliary strap is affected. the remaining components of the sjt are not impacted by this recall and function as intended. it was determined through customer feedback and subsequent internal testing that the rear retaining clip failed in a very small number of devices during training demonstrations. no report of patient injury nor has the device been reported to fail during actual patient use.