Events

Retiro De Equipo (Recall) de Novus TIGRR® Matrix Surgical Mesh

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 Novus Scientific AB.

¿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
    20455
  • Fecha de inicio del evento
    2016-08-01
  • 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: Clinical & Regulatory Services Limited, 50B Puketapu Road, Taradale, Napier 4112
  • Causa
    The product's instructions for use (ifu) have been updated based on the 3-year follow up of a clinical study. in the study the patients with direct (medial and combined) inguinal hernia showed relative high recurrence rates. the patient group is considered unable to form scar tissue strong enough to replace the mesh, leading to the conclusion that a permanent mesh is required.
  • Acción
    Instructions for use to be updated

Device

Novus TIGRR® Matrix Surgical Mesh
  • Modelo / Serial
    Model: NSTM1015E, NST152OE and NSTM2030E, Affected:
  • Manufacturer
    Novus Scientific AB

Manufacturer

Novus Scientific AB