Events

Field Safety Notices about Duowire™ Bi-Flex

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 Coloplast A/S.

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
    1367
  • Date
    2017-12-01
  • 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

Duowire™ Bi-Flex
  • Model / Serial
    Catalog Number: AEBD35 Batch Number: Lot Coloplast 3805926/supplier lots 91303666 and 91303667 - manufacturing date 09-2013, expiry date 08-2018 Lot Coloplast 4413375/supplier lot 91405680 - manufacturing date 11-2014, expiry date 10-2019 Lot Coloplast 4413376/supplier lot 91500532 - manufacturing date 02-2015, expiry date 01-2020/supplier lot 91405681- manufacturing date 04-2015, expiry date 03-2020. Lot Coloplast 4614015/supplier lots 91502257 and 91502429 manufacturing date 04-2015, expiry date 03-2020
  • Product Description
    Medical devices for single use
  • Manufacturer
    Coloplast A/S

Manufacturer

Coloplast A/S