Events

Retiro De Equipo (Recall) de STANDARD SLINGBAR 450

Según Health Canada (via FOI), este evento ( retiro de equipo (recall) ) involucró a un dispositivo médico en Canada que fue producido por HILL-ROM CANADA 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
    Recall
  • ID del evento
    83019
  • Clase de Riesgo del Evento
    III
  • Fecha de inicio del evento
    2012-04-09
  • 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
    There have been 6 complaints of injury related to the product over the past 32 years (6 out of 838687856 estimated patient uses). one of the injuries was associated with a patient during use four injuries occurred when the slingbar was not in use where someone tripped and fell onto the unit and one where a child was playing on a lift and was injured when they tried to jump from the lift.

Device

STANDARD SLINGBAR 450
  • Modelo / Serial
    Model Catalog: N/A (Lot serial: 3156007); Model Catalog: N/A (Lot serial: 20090029); Model Catalog: N/A (Lot serial: 20190024); Model Catalog: N/A (Lot serial: 20190041); Model Catalog: N/A (Lot serial: 31190015); Model Catalog: N/A (Lot serial: 31290017); Model Catalog: N/A (Lot serial: 31290043); Model Catalog: N/A (Lot serial: 3156001); Model Catalog: N/A (Lot serial: 3156003); Model Catalog: N/A (Lot serial: 3156014); Model Catalog: N/A (Lot serial: 3156016); Model Catalog: N/A (Lot serial: 31590043); Model Catalog: N/A (Lot serial: 5019013)
  • Descripción del producto
    STANDARD SLINGBAR 450
  • Manufacturer
    HILL-ROM CANADA LTD.

Manufacturer

HILL-ROM CANADA LTD.