Events

Rappel de TEOSYAL PURESENSE REDENSITY II

Selon Health Canada (via FOI), ce/cet/cette rappel concerne un dispositif en/au/aux/à Canada qui a été fabriqué par CLARION MEDICAL TECHNOLOGIES INC..

Qu'est-ce que c'est?

Une correction ou un retrait opéré par un fabricant afin de répondre à un problème causé par un dispositif médical. Les rappels surviennent lorsqu'un dispositif médical est défectueux, lorsqu'il pourrait poser un risque pour la santé, ou les deux à la fois.

En savoir plus sur les données ici
  • Type d'événement
    Recall
  • ID de l'événement
    16025
  • Classe de risque de l'événement
    II
  • Date de mise en oeuvre de l'événement
    2014-06-06
  • Pays de l'événement
    Canada
  • Source de l'événement
    HC
  • Notes / Alertes
    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.
  • Notes supplémentaires dans les données
  • Cause
    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.

Device

TEOSYAL PURESENSE REDENSITY II
  • Modèle / numéro de série
    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
  • Description du dispositif
    TEOSYAL PURESENSE REDENSITY II
  • Manufacturer
    CLARION MEDICAL TECHNOLOGIES INC.

Manufacturer

CLARION MEDICAL TECHNOLOGIES INC.