Events

Field Safety Notices about Solysafe Septal Occluder

According to ALIMS (Agencija za lekove i medicinska sredstva), this field safety notices involved a device in Serbia that was produced by Swissimplant AG.

What is this?

Field safety notices are communications sent out by medical device manufacturers or their representatives in relation to actions that they may be taking in relation to their product that is on the market. These are mainly for health workers, but also for users. They can include recalls and alerts.

Learn more about the data here
  • Type of Event
    Field Safety Notice
  • Event Date Posted
    2010-08-16
  • Event Country
    Serbia
  • Event Source
    ALIMSA
  • Event Source URL
    https://www.alims.gov.rs/latin/2010/08/16/hitno-povlacenje-solysafe-septal/
  • Notes / Alerts
    Serbian data is current through February 2018. All of the data comes from ALIMS (Agencija za lekove i medicinska sredstva), 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 Serbia.
  • Extra notes in the data
  • Reason
    After receiving multiple reports of adverse reactions to the specified medical device (all related to diameters 30 and 35), the manufacturer decided to implement an urgent measure to suspend the installation, circulation, sale, and distribution of all solysafe septal occluder medical models. the manufacturer also recommended that all patients who were referred to undergo an emergency radiological examination.

Device

Solysafe Septal Occluder

Manufacturer

Swissimplant AG
  • Source
    ALIMSA