Events

Retiro De Equipo (Recall) de Otto Bock 4R82 Tube Clamp Adapter

Según New Zealand Medicines and Medical Devices Safety Authority, este evento ( retiro de equipo (recall) ) involucró a un dispositivo médico en New Zealand que fue producido por Otto Bock Healthcare GmbH.

¿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
    13187
  • Fecha de inicio del evento
    2012-07-23
  • País del evento
    New Zealand
  • Fuente del evento
    NZMMDSA
  • URL de la fuente del evento
    https://medsafe.govt.nz/hot/Recalls/RecallSearch.asp
  • Notas / Alertas
    Data from New Zealand is current through July 2018. All of the data comes from the New Zealand Medicines and Medical Devices Safety Authority, 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 New Zealand.
  • Notas adicionales en la data
    Recalling Organisation: Ottobock Australia Pty, Suite 1.01 Century Corporate Centre, 62 Norwest Boulevarde, Baulkham Hills, NSW 2153, AUSTRALIA
  • Causa
    The manufacturer received some complaints about adapters that show a crack starting at the clamping of the adapter into direction of the clamping slot. due to the crack, the clamping to the tube adapter is lost and the prosthesis twists when loaded. depending on the situation this may cause the patient to fall.
  • Acción
    Product to be returned to supplier

Device

Otto Bock 4R82 Tube Clamp Adapter

Manufacturer

Otto Bock Healthcare GmbH