Events

Field Safety Notices about EDS 3 CSF External Drainage Systems

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

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
  • Date
    2014-12-09
  • Event Date Posted
    2014-08-10
  • Event Country
    Serbia
  • Event Source
    ALIMSA
  • Event Source URL
    https://www.alims.gov.rs/latin/2014/10/08/obavestenje-o-meri-povlacenja-sa-trzista-medicinskog-sredstva-codman-eds3-csf-external-drainage-system/
  • 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
    This withdrawal from the market has been triggered because the pipe inside this csf-draining system can leak or disconnect from assemblies. leakage and separation of the tubes may result in excessive or insufficient drainage of the csf from the ventricular system or the introduction of air into the ventricular system (pneumocephalus). it can lead to ventricular collapse, subdural bleeding or inability to properly control elevated intracranial pressure. tumor disconnection or leakage can also increase the risk of ventriculitis. failure to detect or treat these events can cause severe brain injury that can result in a coma, brain stroke or death.

Device

EDS 3 CSF External Drainage Systems

Manufacturer

Codman Neuro