Events

Retiro De Equipo (Recall) de TEOSYAL PURESENSE REDENSITY II

Según Health Canada (via FOI), este evento ( retiro de equipo (recall) ) involucró a un dispositivo médico en Canada que fue producido por CLARION MEDICAL TECHNOLOGIES INC..

¿Qué es esto?

Una corrección al equipo o acción de retiro tomada por el fabricante para abordar un problema con un dispositivo médico. Los retiros (recalls) ocurren cuando un dispositivo médico está defectuoso, cuando puede poner en riesgo la salud, o cuando simultáneamente está defectuoso y puede poner en riesgo la salud.

Más información acerca de la data acá
  • Tipo de evento
    Recall
  • ID del evento
    16025
  • Clase de Riesgo del Evento
    II
  • Fecha de inicio del evento
    2014-06-06
  • País del evento
    Canada
  • Fuente del evento
    HC
  • Notas / Alertas
    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.
  • Notas adicionales en la data
  • Causa
    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
  • Modelo / Serial
    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
  • Descripción del producto
    TEOSYAL PURESENSE REDENSITY II
  • Manufacturer
    CLARION MEDICAL TECHNOLOGIES INC.

Manufacturer

CLARION MEDICAL TECHNOLOGIES INC.