Events

Field Safety Notices about Bander Ureteral Diversion Open-End Stent Set, Percutaneous Entry Set, Percutaneous Pigtail Nephrostomy Set, PTFE Wire Guide, Roadrunner® Hydrophilic PC Wire Guide, Sof-Flex® Double Pigtail Ureteral Stent Set, Sof-Flex® MultiLength Ureteral Stent Set, Universa® Soft Ureteral Stent Set, Urethral Dilation Balloon Catheter with Open Tip

According to Danish Medicines Agency, this field safety notices involved a device in Denmark that was produced by Cook Incorporated.

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
    2019022428
  • Date
    2019-02-15
  • Event Country
    Denmark
  • Event Source
    DMA
  • Event Source URL
    https://laegemiddelstyrelsen.dk/da/udstyr/sikkerhedsmeddelelser/2019/2/certain-cook-wire-guides/
  • Notes / Alerts
    Danish data is current through March 2019. All of the data comes from the Danish Medicines Agency, 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 Denmark.
  • Extra notes in the data

Device

Bander Ureteral Diversion Open-End Stent Set, Percutaneous Entry Set, Percutaneous Pigtail Nephro...

Manufacturer

Cook Incorporated