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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During use with the tenor without scale unit the part# ten.018 bolt is subjected to mechanical forces which may lead to breakage due to the design of the connection between spreader bar and lifting arm jig. the current design of suspension of the tenor spreader bar is causing adverse bending tension on suspension bolt ten.018 during specific use situations such as the load mass of the patient is unevenly placed in the sling the caregiver attempts to move the lift by pushing or pulling the suspended patient body sling or spreader bar. this is revealed in long term use as metal fatigue and the formation of micro-cracks in the thread.