Events

Alerta De Seguridad para Gastrointestinal lining with placement and extraction system

Según National Institute of Drugs and Food Surveillance (INVIMA), este evento ( alerta de seguridad ) involucró a un dispositivo médico en Colombia que fue producido por GI Dynamics, Inc.

¿Qué es esto?

Las alertas proporcionan información importante y recomendaciones sobre los productos. Aunque se haya emitido una alerta, esto no significa necesariamente que el producto se considera peligroso. Las alertas de seguridad, dirigidas a trabajadores de la salud y a usuarios, pueden incluir retiro de equipos. Pueden ser escritas por los fabricantes, pero también por funcionarios del área de salud.

Más información acerca de la data acá
  • Tipo de evento
    Safety alert
  • ID del evento
    I1503-106
  • Número del evento
    2013DM-0010120
  • Fecha
    2015-03-09
  • País del evento
    Colombia
  • Fuente del evento
    INVIMA
  • URL de la fuente del evento
    https://app.invima.gov.co/alertas/dispositivos-medicos-invima?page=183
  • Notas / Alertas
    Colombian data is current through June 2019. All of the data comes from the National Institute of Drugs and Food Surveillance (INVIMA), 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 Colombia.
  • Notas adicionales en la data
  • Causa
    The manufacturer states that it will make changes in its use indications, specifying the patient's conditions and possible side effects to clarify the indication of obesity and include a restriction for patients with a body mass index (bmi) ≥ 30 kg / m2, with the objective to avoid presenting possible adverse events on patients.

Device

Gastrointestinal lining with placement and extraction system
  • Modelo / Serial
    40-10-00364
  • Descripción del producto
    The gastrointestinal lining ENDOBARRIER with placement system of GI DYNAMICS is used for the treatment of type 2 diabetes and / or obesity. It appears sterile and consists of a gastrointestinal lining (anchoring and lining) preloaded from a catheter that places the lining in the proximal intestine. They are available sterile (ethylene oxide) or non-sterile.
  • Manufacturer
    GI Dynamics, Inc

Manufacturer

GI Dynamics, Inc