Events

Field Safety Notices about Bead Block

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 Biocompatibles UK Ltd..

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
    2015-03-31
  • 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
    Biocompatibles uk ltd. (manufacturer) sends this message to inform you that conflicting labeling has been used for certain sizes of the medical device bead block ™ (embolic bullet). this notification is not due to an increase in complaints or adverse events associated with bead block ™. make sure that all potential users at your institution are made aware of this notice and the recommended actions.

Device

Bead Block
  • Model / Serial
    Bead Block™ (100–300 μm) EB2S103 Bead Block™ (300–500 μm) EB2S305
  • Manufacturer
    Biocompatibles UK Ltd.

Manufacturer

Biocompatibles UK Ltd.
  • Manufacturer Parent Company (2017)
    Btg Plc
  • Source
    AMPMDRS