Events

Retiro De Equipo (Recall) de DANA DOUGLAS NEXUS III MOBILITY WALKER

Según Health Canada (via FOI), este evento ( retiro de equipo (recall) ) involucró a un dispositivo médico en Canada que fue producido por HUMAN CARE CANADA 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
    66159
  • Clase de Riesgo del Evento
    III
  • Fecha de inicio del evento
    2009-12-14
  • 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
    Dealer called to report a broken front fork after use. broken fork sent to manufacturer for testing as well as a third party testing facility. after testing it was determined that some nylon 66 material was found in the part.

Device

DANA DOUGLAS NEXUS III MOBILITY WALKER
  • Modelo / Serial
    Model Catalog: 4500245F (Lot serial: SEE MANUFACTURER.); Model Catalog: 4500225F (Lot serial: SEE MANUFACTURER.); Model Catalog: 4500185F (Lot serial: SEE MANUFACTURER.); Model Catalog: 4500185F (Lot serial: MORE THAN 10 SERIAL NUMBERS); Model Catalog: 4500225F (Lot serial: MORE THAN 10 SERIAL NUMBERS); Model Catalog: 4500245F (Lot serial: MORE THAN 10 SERIAL NUMBERS); Model Catalog: 4520245F (Lot serial: SEE MANUFACTURER.); Model Catalog: 4515185F (Lot serial: MORE THAN 10 SERIAL NUMBERS); Model Catalog: 4520185F (Lot serial: SEE MANUFACTURER.); Model Catalog: 4520245F (Lot serial: MORE THAN 10 SERIAL NUMBERS); Model Catalog: 4520225F (Lot serial: MORE THAN 10 SERIAL NUMBERS); Model Catalog: 4520185F (Lot serial: MORE THAN 10 SERIAL NUMBERS); Model Catalog: 4520225F (Lot serial: SEE MANUFACTURER.); Model Catalog: 4515225F (Lot serial: MORE THAN 10 SERIAL NUMBERS); Model Catalog: 4515245F (Lot serial: MORE THAN 10 SERIAL NUMBERS); Model Catalog: 4515185F (Lot serial: SEE MANUFACTURER.); Model Catalog: 451522
  • Descripción del producto
    NEXUS 3
  • Manufacturer
    HUMAN CARE CANADA INC.

Manufacturer

HUMAN CARE CANADA INC.