Events

Safety Alert for System for Andrology

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

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
    I1512-591
  • Event Number
    2011DM-0007502
  • Date
    2015-12-29
  • Event Country
    Colombia
  • Event Source
    INVIMA
  • Event Source URL
    https://app.invima.gov.co/alertas/dispositivos-medicos-invima?page=163
  • 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 has received a report from a client that reports the development of embryos from 5-6 days of embryos covered with the referenced device, the potential risk is reduced to the development of the embryo, comparing with similar incidents with other oils used for ivf, nothing suggests that there would be an impact of transferred or frozen embryos.

Device

System for Andrology
  • Model / Serial
    NidOil - 100ml lot 100NOVI15
  • Product Description
    These media are used for andrology.
  • Manufacturer
    Nidacon International AB

Manufacturer

Nidacon International AB