Events

Field Safety Notices about PHIL (Precipitating Embolic Injectable Liquid) - a precipitating hydrophobic solution for injection

According to Ministry of Health, State Institute for Drug Control, Coordination Center for Departmental Medical Information Systems, this field safety notices involved a device in Czechia that was produced by MicroVention Europe S.A.R.L..

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 ID
    653
  • Date
    2016-07-19
  • Event Country
    Czechia
  • Event Source
    MHSIDCCCDMIS
  • Event Source URL
    https://eregpublicsecure.ksrzis.cz/Registr/RZPRO/FSN
  • Notes / Alerts
    Czech data is current through July 2018. All of the data comes from the Czech Public Registry of Medical Devices, 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 data from the U.S. and the Czech Republic.
  • Extra notes in the data

Device

PHIL (Precipitating Embolic Injectable Liquid) - a precipitating hydrophobic solution for injection
  • Model / Serial
    Catalog Number: LEN10250, LEN10300, LEN10350 Model Number: LEN10250, LEN10300, LEN10350 Batch Number: LEN10250 - 14072421 14082026 14100227 14103026 14120837 14120840 14120929 15020632 15021329 15022521 15030528 15031035 15031921 15032332 15032526 15040631 15041526 15042724 15042725 15042726 15051144 15051145 15051146 15051840 15052122 15052631 15052634 15052635 15061222 15061223 15062233 15062529 15062536 15062537 15070128 15071326 15072222 15072224 15072436 15072826 15072827 15080423 15080622 15080742 15080821 15081829 15090329 15090521 15090824 15090923 15090932 15091423 15091621 15100242 15101223 15101326 15102026 15102121 15102326 15102723 15120247 15120823 15120928 15121622 16010148 16010821 16040534 16050421 16051836B LEN10300 - 14061834 14072422 14082027 14103027 14120838 15010743 15020633 15021330 15030529 15031036 15031922 15032333 15032527 15042727 15051147 15052632 15052636 15052637 15072223 15072435 15080335 15080621 15091424 15092123 15100346 15111921 16010528 16031421 LEN10350 - 14061835 14072423 14103028 15010744 15020634 15021331 15022522 15030527 15031037 15031334 15031923 15032334 15032528 15042728 15052123 15062538 15062539 15072828 15080336 15091029 15092124 15120132 16010637 15010744M
  • Product Description
    Inactive implantable medical devices
  • Manufacturer
    MicroVention Europe S.A.R.L.

Manufacturer

MicroVention Europe S.A.R.L.