Events

Safety Alert for Drainage Valve System for Hydrocephalus

According to National Institute of Drugs and Food Surveillance (INVIMA), this safety alert involved a device in Colombia that was produced by Sophysa..

What is this?

Alerts provide important information and recommendations about products. Even though an alert has been issued, it does not necessarily mean a product is considered to be unsafe. Safety Alerts, addressed to health workers and users, may include recalls. They can be written by manufacturers, but also by health officials.

Learn more about the data here
  • Type of Event
    Safety alert
  • Event ID
    I1512-542
  • Event Number
    2009DM-0004256
  • Date
    2015-12-03
  • Event Country
    Colombia
  • Event Source
    INVIMA
  • Event Source URL
    https://app.invima.gov.co/alertas/dispositivos-medicos-invima?page=164
  • Notes / Alerts
    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.
  • Extra notes in the data
  • Reason
    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
  • Model / Serial
    DE-306 and DE-308, specific lots.
  • Product Description
    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.
  • Manufacturer Parent Company (2017)
    Sophysa
  • Source
    NIDFSINVIMA