Events

Retiro De Equipo (Recall) de MORCELLEX SIGMA - GENERATOR

Según Health Canada (via FOI), este evento ( retiro de equipo (recall) ) involucró a un dispositivo médico en Canada que fue producido por JOHNSON & JOHNSON MEDICAL PRODUCTS A DIV. OF JOHNSON & JOHNSON 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
    28623
  • Clase de Riesgo del Evento
    II
  • Fecha de inicio del evento
    2014-05-01
  • 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
    Customers are being made aware that the us fda issued a safety communication on april 17 2014 discouraging the use of laparoscopic uterine power morcellation in hysterectomy or myomectomy in women with uterine fibroids because of the risk of spreading unsuspected cancerous tissue notably uterine sarcomas beyond the uterus. health care providers should carefully consider alternative treatment options for symptomatic uterine fibroids.

Device

MORCELLEX SIGMA - GENERATOR
  • Modelo / Serial
    Model Catalog: MD0200 (Lot serial: ALL LOTS); Model Catalog: DV0015 (Lot serial: ALL LOTS); Model Catalog: MX0200R (Lot serial: ALL LOTS); Model Catalog: MD0100 (Lot serial: ALL LOTS); Model Catalog: MD0120 (Lot serial: ALL LOTS); Model Catalog: MX0200 (Lot serial: ALL LOTS); Model Catalog: MX0100R (Lot serial: ALL LOTS); Model Catalog: MX0100 (Lot serial: ALL LOTS)
  • Descripción del producto
    MORCELLEX SIGMA - GENERATOR
  • Manufacturer
    JOHNSON & JOHNSON MEDICAL PRODUCTS A DIV. OF JOHNSON & JOHNSON INC.

Manufacturer

JOHNSON & JOHNSON MEDICAL PRODUCTS A DIV. OF JOHNSON & JOHNSON INC.
  • Dirección del fabricante
    MARKHAM
  • Empresa matriz del fabricante (2017)
    Johnson & Johnson
  • Source
    HC