Events

Avis De Sécurité sur Trix, Kettwiesel, and Trets Reh

Selon Agency for Medicinal Products and Medical Devices of the Republic of Slovenia (via FOI), ce/cet/cette avis de sécurité concerne un dispositif en/au/aux/à Slovenia qui a été fabriqué par Hase Bikes.

Qu'est-ce que c'est?

Les avis de sécurité sont des communications que les fabricants de dispositifs médicaux ou leurs représentants font parvenir en particulier aux travailleurs du secteur médical, mais aussi aux utilisateurs de ces dispositifs. Les avis de sécurité concernent les actions entreprises quant aux dispositifs présents sur le marché et peuvent inclure des rappels et des alertes.

En savoir plus sur les données ici
  • Type d'événement
    Field Safety Notice
  • Pays de l'événement
    Slovenia
  • Source de l'événement
    AMPMDRS
  • Notes / Alertes
    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.
  • Notes supplémentaires dans les données
  • Cause
    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
  • Modèle / numéro de série
  • Manufacturer
    Hase Bikes

Manufacturer

Hase Bikes
  • Source
    AMPMDRS