Events

Field Safety Notices about All Gelsoft, Gelsoft ERS, Gelsoft Plus, Gelsoft Plus ERS, Gelseal, Gelseal ERT, Gelweave, K-Thin, K-Thin ERS, and Gelseal Plus Vascular Prostheses. All Fluoropassiv, Fluoropassiv ER, Thin Wall Fluoropassiv and Thin Wall Fluoropassiv ER Vascular Prostheses. All Cariovascular Fabric Patches. All Seal PTFE and Taperflo Vascular Prostheses

According to Health Products Regulatory Authority, this field safety notices involved a device in Ireland that was produced by Vascutek Limited.

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 Number
V34012
Event Country
Ireland
Event Source
HPRA
Event Source URL
http://www.hpra.ie/homepage/medical-devices/safety-information/safety-notices/item?t=/summary-of-field-safety-notices---december-2017&id=bc570a26-9782-6eee-9b55-ff00008c97d0
Notes / Alerts

Irish data is current through April 2019. All of the data comes from the Health Products Regulatory Authority (Ireland), 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 Ireland.
Extra notes in the data

Advice regarding the use of the device. 3rd Party Publications

Device

All Gelsoft, Gelsoft ERS, Gelsoft Plus, Gelsoft Plus ERS, Gelseal, Gelseal ERT, Gelweave, K-Thin,...

Model / Serial
Manufacturer
Vascutek Limited

Manufacturer

Vascutek Limited

Manufacturer Parent Company (2017)
Terumo Corp.
Source
HPRA

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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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