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&d may have shipped blood pressure monitors that were not labeled for use with small cuff. the device is intended to be used with arm sizes from 5.1 inches to 17.7 inches or small cuffs (6.3-9.4") medium cuffs ( 9.4-14.2") and large cuffs (14.2-17.7"). for optimal comfort the manufacturer adjusts the exhaust valve for the devices to be used with a small cuff. in doing so the manufacturer may have not provided clear labeling on the front of these devices to indicate they have been adjusted for small cuff use. additionally some devices may have been labeled "adjusted for small cuffs" but may have been equipped with a medium cuff.