Events

Field Safety Notices about NIO-A

According to Agency for Medicinal Products and Medical Devices of the Republic of Slovenia (via FOI), this field safety notices involved a device in Slovenia that was produced by WaisMed.

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
  • Date
    2016-08-16
  • Event Country
    Slovenia
  • Event Source
    AMPMDRS
  • Notes / Alerts
    Data from Slovenia is current through February 2019. All of the data comes from the Agency for Medicinal Products and Medical Devices of the Republic of Slovenia (via FOI), 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 recall data from the U.S. and Slovenia.
  • Extra notes in the data
  • Reason
    During the operation of the nio-a, the needle was not released from the device as expected. the device was placed on the floor and after several minutes the needle was released spontaneously. .

Device

NIO-A
  • Model / Serial
    WS1630025 03/2016 03/2021 WS1630024 02/2016 02/2021 WS1630023 01/2016 01/2021 WS1530021 12/2015 12/2020 WS1530017 10/2015 10/2020 WS1530016 09/2015 09/2020 WS1530014 08/2015 08/2020 WS1530012 06/2015 06/2020
  • Manufacturer
    WaisMed

Manufacturer

WaisMed