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 foreign incident involving a 48 year old female with a known history of severe allergies was injected with teosyal causing anaphylactic shock (a known and listed contra-indication). while there are no product specific issues the amending of the ifu's (to include anaphylactic shock in the side effects section) has resulted in the classification of a recall.
Model Catalog: TEOSYAL PURESENSE REDENSITY II (Lot serial: all); Model Catalog: TEOSYAL PURESENSE REDENSITY II (BD) (Lot serial: all); Model Catalog: TEOSYAL PURESENSE REDENSITY II (TSK) (Lot serial: all); Model Catalog: TEOSYAL PURESENSE ULTRA DEEP (1.2ML) (TR) (Lot serial: all); Model Catalog: TEOSYAL PURESENSE ULTRA DEEP (TR) (Lot serial: all); Model Catalog: TEOSYAL PURESENSE ULTRA DEEP (TSK) (Lot serial: all); Model Catalog: TEOSYAL PURESENSE ULTRA DEEP (1.2ML) (TSK) (Lot serial: all); Model Catalog: TEOSYAL PURESENSE FIRST LINES (BD) (Lot serial: all); Model Catalog: TEOSYAL PURESENSE DEEP LINES (TSK) (Lot serial: all); Model Catalog: TEOSYAL PURESENSE KISS (TR) (Lot serial: all); Model Catalog: TEOSYAL PURESENSE KISS (TSK) (Lot serial: all); Model Catalog: TEOSYAL PURESENSE FIRST LINE (TSK) (Lot serial: all); Model Catalog: TEOSYAL PURESENSE DEEP LINES (TR) (Lot serial: all); Model Catalog: TEOSYAL PURESENSE GLOBAL ACTION (TSK) (Lot serial: all); Model Catalog: TEOSYAL PURESENSE GLOBAL ACTION (TR) (Lo