Events

Alerta De Seguridad para Drainage Valve System for Hydrocephalus

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 Sophysa..

¿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
    I1512-542
  • Número del evento
    2009DM-0004256
  • Fecha
    2015-12-03
  • País del evento
    Colombia
  • Fuente del evento
    INVIMA
  • URL de la fuente del evento
    https://app.invima.gov.co/alertas/dispositivos-medicos-invima?page=164
  • 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 the external identification of the medical device drain kit may be different for the corresponding record according to the way of identifying it, either by the batch and serial number or by the barcode, leading to potential confounding in its use and for the patient.

Device

Drainage Valve System for Hydrocephalus
  • Modelo / Serial
    DE-306 and DE-308, specific lots.
  • Descripción del producto
    Drainage of cerebrospinal fluid for the management of hydrocephalus by means of derivation of excess cerebral spinal fluid inside the intracranial cavity towards other places where it can be absorbed as the abdominal cavity, the right atrium of the heart or towards drains selected by the doctor. Treatment of: congenital hydrocephalus, communicating hydrocephalus not communicating, hydrocephalus ex vacuo, pressure hydrocephalus normal. The components of the hydrocephalus valve system SOPHYSA are indicated to be used exclusively with SOPHYSA components in the selected combinations according to the needs of the patient and the medical instructions for the drainage of cerebrospinal fluid in the management of hydrocephalus.
  • Manufacturer
    Sophysa.

Manufacturer

Sophysa.
  • Empresa matriz del fabricante (2017)
    Sophysa
  • Source
    NIDFSINVIMA