Events

Field Safety Notices about Teosyal® Ultimate and Teosyal® PureSense Ultimate

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 TEOXANE.

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
    An internal audit revealed that we have launched three teosyal® ultimate and teosyal® puresense product series ultimate with needles that expire three to seven months before the expiry date stated on the packaging product.

Device

Teosyal® Ultimate and Teosyal® PureSense Ultimate
  • Model / Serial
    TST-142103 Ves Teosyal® Ultimate 2016-05-31 2016-02-29 TSTL-143902 Ves Teosyal® PureSense Ultimate 2016-09-30 2016-02-29 TSTL-154704 TSTL-1547045xxx TSTL-1547046xxx TSTL-1547047xxx Teosyal® PureSense Ultimate 2017-11-30 2017-06-30
  • Manufacturer
    TEOXANE

Manufacturer

TEOXANE