Events

Retiro De Equipo (Recall) de REALIZE (GENERATION 2) GASTRIC BAND WITH INJECTION PORT AND APPLIER

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
    97170
  • Clase de Riesgo del Evento
    II
  • Fecha de inicio del evento
    2010-10-08
  • 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 manufacturer has received reports of the tubing strain relief component of the realize injection port becoming displaced from the locking connector and in some cases migrating from its original position on the locking connector. displacement of the strain relief component may result in kinking of the catheter which may prevent adjustment of fluid volume potentially rendering the product ineffective and requiring additional surgery to correct. in addition the strain relief component may migrate and become a foreign body within the abdomen which may require surgery to remove. implanted devices do not need to be removed because of this recall.

Device

REALIZE (GENERATION 2) GASTRIC BAND WITH INJECTION PORT AND APPLIER
  • Modelo / Serial
    Model Catalog: BD2XV (Lot serial: >10 NUMBERS CONTACT MFR); Model Catalog: BD3XV (Lot serial: >10 NUMBERS CONTACT MFR); Model Catalog: PT2XV (Lot serial: >10 NUMBERS CONTACT MFR)
  • Descripción del producto
    REALIZE ADJUSTABLE GASTRIC BAND
  • 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