Events

Field Safety Notices about Trix, Kettwiesel, and Trets Reh

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 Hase Bikes.

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 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
    In 2017, the following incident involving a hase bikes trailer kit was reported to us: a child seated in a trike that was being pulled as a trailer took their hands off the handlebars and touched one of the brake discs, injuring themselves. this was the first incident of its kind to be reported to hase bikes. the associated risk only applies to models without rear suspension. in response to this incident, we would like to ensure that all users are informed that children who are being pulled in the trix/ketmiesel/trets must be instructed by the accompanying adult to keep their hands on the handlebar grips at all times and never touch the brake discs or wheels. .

Device

Trix, Kettwiesel, and Trets Reh

Manufacturer

Hase Bikes
  • Source
    AMPMDRS