International Medical Devices Database

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.

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Type of Event
Field Safety Notice
Event ID
314
Date
2015-11-24
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

ala®octa

Model / Serial
Catalog Number: PN 101001, PN 101002, PN 101003, PN 101004 Batch Number: PFO 200612 PN: 101001, 101003 PFO 040712 PN: 101004 PFO 060912 PN: 101001, 101003 PFO 241012 PN: 101002 PFO 261112 PN: 101001, 101003 PFO 171212 PN: 101002, 101004 PFO 110213 PN: 101001, 101003 PFO 030713 PN: 101002, 101004 PFO 170713 PN: 101001, 101003 PFO 060813 PN: 101002, 101004 PFO 041213 PN: 101004 PFO 200114 PN: 101002, 101004 PFO 180214 PN: 101001, 101003 PFO 150414 PN: 101004 PFO 050514 PN: 101002, 101004 PFO 070714 PN: 101002, 101004 PFO 080714 PN: 101003
Product Description
Inactive implantable medical devices
Manufacturer
alamedics GmbH & Co.KG

Manufacturer

alamedics GmbH & Co.KG

Manufacturer Parent Company (2017)
Alamedics Gmbh & Co. Kg
Source
MHSIDCCCDMIS

About this database

Explore more than 120,000 Recalls, Safety Alerts and Field Safety Notices of medical devices and their connections with their manufacturers.

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Disclaimer

Medical devices help to diagnose, prevent and treat many injuries and diseases. We are not suggesting or implying that any companies or other entities included in the International Medical Devices Database engaged in unlawful conduct or otherwise acted improperly. The same device may have different names in different countries. This database is not intended to provide medical advice and patients should check with their doctors to determine if it contains relevant information and if such information has medical implications for them.

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The International Medical Devices Database is licensed under the Open Database License and its contents under Creative Commons Attribution-ShareAlike license. Always cite the International Consortium of Investigative Journalists when using this data. You can download a raw copy of the database here.

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Field Safety Notices about ala®octa

What is this?

Device

ala®octa

Manufacturer

alamedics GmbH & Co.KG