Events

Retiro De Equipo (Recall) de CONFIDENCE INTRODUCER NEEDLE SIDE HOLE

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
    154027
  • Clase de Riesgo del Evento
    II
  • Fecha de inicio del evento
    2012-05-25
  • 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
    During post market surveillance review of the confidence spinal cement system it was found that the complaint rate for breakage of the side fire needles was higher than the anticipated occurrence rate. to reduce the level of risk a communication has been sent out to all users of the product to reinforce proper technique and instructions for use.

Device

CONFIDENCE INTRODUCER NEEDLE SIDE HOLE
  • Modelo / Serial
    Model Catalog: 2839-04-613 (Lot serial: HLDB5L); Model Catalog: 2839-04-411 (Lot serial: HLFBC4); Model Catalog: 2839-04-611 (Lot serial: HLFBC4); Model Catalog: 2839-04-613 (Lot serial: HLFBC4); Model Catalog: 2839-04-411 (Lot serial: HLDB02); Model Catalog: 2839-04-411 (Lot serial: HLDB5L); Model Catalog: 2839-04-613 (Lot serial: HLDB02); Model Catalog: 2839-04-611 (Lot serial: HLDB02); Model Catalog: 2839-04-611 (Lot serial: HLDB5L); Model Catalog: 2839-04-413 (Lot serial: HLKBDD); Model Catalog: 2839-04-413 (Lot serial: CJNBWN); Model Catalog: 2839-04-413 (Lot serial: CJPCBZ); Model Catalog: 2839-04-413 (Lot serial: CJPB8Z); Model Catalog: 2839-04-413 (Lot serial: CJPCB1); Model Catalog: 2839-04-413 (Lot serial: CKBBW5)
  • Descripción del producto
    CONFIDENCE SPINAL SIDE FIRE NEEDLES
  • 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