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

¿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
  • ID del evento
  • Clase de Riesgo del Evento
  • Fecha de inicio del evento
  • País del evento
  • Fuente del evento
  • 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
    The purpose of this communication is to provide the updated labeling for essure. this notice does not include a stock recovery or any physical changes to product currently in use or on the market. labeling changes include revised essure instructions for use (ifu) and a patient information brochure (pib) that includes a patient-doctor discussion checklist (checklist). a summary of changes to the labeling includes: 1-the addition of a boxed warning listing information on the essure confirmation test adverse events that have been reported either in clinical studies or through post market surveillance and situations where device removal may be indicated. 2-the ifu has also been updated with additional information. this includes a new section on patient counseling in addition to revisions in the sections discussing safety clinical studies instructions for use and patient management. 3-the introduction of a pib including a checklist. the pib along with the checklist is intended to be reviewed by the physician and patient to facilitate the patient's understanding of birth control options benefits and potential risks associated with the use of essure as well as what to expect during and after the essure procedure.


  • Modelo / Serial
    Model Catalog: ESS 305 (Lot serial: All Lots)
  • Descripción del producto
    ESSURE Contraceptive Device for Hysteroscopic Placement;ESSURE PERMANENT BIRTH CONTROL SYSTEM
  • Manufacturer