Events

Field Safety Notices about Connectable Pusher CH/FR 4.8/75cm REF YN2813 included in the following kits: VORTEK Double Loop Ureteral Stent Open/Open With Connectable Pusher and VORTEK Hydro- Coated Double Loop Ureteral Stents

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

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
V18291
Date
2013-07-19
Event Country
Ireland
Event Source
HPRA
Event Source URL
http://www.hpra.ie/docs/default-source/field-safety-notices/jan-dec-2014-fsn-summary-sheets/fsnsummary_aug2013_qmsversion_updated_230714.pdf?sfvrsn=2
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 a device removal. 3rd Party Publications

Device

Connectable Pusher CH/FR 4.8/75cm REF YN2813 included in the following kits: VORTEK Double Loop...

Model / Serial
Product Description
Connectable Pusher CH/FR 4.8/75cm REF YN2813 included in the following kits: VORTEK Double Loop Ureteral Stent Open/Open With Connectable Pusher and VORTEK Hydro- Coated Double Loop Ureteral Stents
Manufacturer
Coloplast

Manufacturer

Coloplast

Manufacturer Parent Company (2017)
Coloplast A/S
Source
HPRA

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