Events

Retiro De Equipo (Recall) de VAGINAL STENT INFLATABLE

Según Health Canada (via FOI), este evento ( retiro de equipo (recall) ) involucró a un dispositivo médico en Canada que fue producido por COLOPLAST CANADA CORPORATION.

¿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
    46551
  • Clase de Riesgo del Evento
    II
  • Fecha de inicio del evento
    2015-10-15
  • 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
    The ec certificate of all medical devices from the manufacturer silimed who is a subcontractor to coloplast has been temporarily suspended by their notified body due to particles found at the surface of some breast implants. there is no indication that these issues would pose a threat to the implanted person's safety. the suspension also affects vaginal stents placed on the market by coloplast. in line with recommendations from the authorities coloplast request that all affected devices with silimed as point of origin should be put in quarantine and that use of these devices should be ceased until further notice.

Device

VAGINAL STENT INFLATABLE
  • Modelo / Serial
    Model Catalog: VS3026 (Lot serial: ALL); Model Catalog: VS3022 (Lot serial: ALL); Model Catalog: VS3024 (Lot serial: ALL); Model Catalog: VS3020 (Lot serial: ALL)
  • Descripción del producto
    VAGINAL STENT - INFLATABLE
  • Manufacturer
    COLOPLAST CANADA CORPORATION

Manufacturer

COLOPLAST CANADA CORPORATION
  • Dirección del fabricante
    CONCORD
  • Empresa matriz del fabricante (2017)
    Coloplast A/S
  • Source
    HC