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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Penumbra has become aware of complaints involving devices where the operator complained of damage to the tip of the neuron max mp catheter after removal from the packaging. upon evaluation of the returned devices penumbra confirmed that the polymer at the distal tip of the device had been damaged. further investigation determined that the sticker adhesive used to secure the packaging mandrel to the packaging card was less sticky then previous lots of stickers.