Events

Field Safety Notices about BioMatrix Flex and BioMatrix NeoFlex

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 Biosensors Europe SA.

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
    462
  • Date
    2016-03-14
  • 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

BioMatrix Flex and BioMatrix NeoFlex
  • Model / Serial
    Model Number: BioMatrix Flex: BMX-3511, BMX-3518, BMX-3524, BMX-4018 BioMatrix NeoFlex: BMXP-3511, BMXP-3518, BMXP-4018, BMXP-4024 Batch Number: BioMatrix Flex: Model: BMX-3511 - LOT K15100009 Model: BMX-3518 - LOT K15100011 Model: BMX-3518 - LOT K15110086 Model: BMX-3524 - LOT K15110054 Model: BMX-4018 - LOT K15100017 Model: BMX-4018 - LOT K15110058 Model: BMX-4018 - LOT K15120029 BioMatrix NeoFlex Model: BMXP-3511 - LOT W15100458 Model: BMXP-3518 - LOT W15100236 Model: BMXP-3518 - LOT W15100237 Model: BMXP-3518 - LOT W15100238 Model: BMXP-3518 - LOT W15110083 Model: BMXP-3518 - LOT W15110086 Model: BMXP-3518 - LOT W15120234
  • Product Description
    Inactive implantable medical devices
  • Manufacturer
    Biosensors Europe SA

Manufacturer

Biosensors Europe SA