Safety Alert Or Field Safety Notices for Prosan Flexi-T 300 intrauterine devices - batch 01A1

According to Medicines and Healthcare products Regulatory Agency, this safety alert or field safety notices involved a device in United Kingdom that was produced by Prosan International B.V..

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.

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  • Type of Event
    Safety alert / Field Safety Notice
  • Event ID
  • Event Number
  • Date
  • Event Country
  • Event Source
  • Event Source URL
  • Notes / Alerts
    Data from the United Kingdom is current through April 2019. All of the data comes from the Medicines and Healthcare products Regulatory Agency, 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 the United Kingdom.
  • Extra notes in the data
  • Reason
    Detachment of control threads. mhra has received 19 reports of detachment of control threads from flexi-t 300 intrauterine devices. most of the reported incidents relate to batch number 01a1. batch details are not available for the remaining incidents. batch 01a1 was manufactured in 2001 and the last uk delivery date for this batch was 01 may 2003. the control threads may become detached on attempting to remove the device, making removal more difficult. the manufacturer issued advice to customers in 2003 and issued a reminder in january 2005 (see appendices 1 and 2). mhra is issuing this alert to ensure that all healthcare professionals involved in the placement and removal of these devices are aware of the manufacturer's advice on how to proceed in cases of difficult removal and on the use of anaesthesia. please note that the local anaesthetic described in the expert report from the manufacturer (appendix 2) is not licensed for this indication in the uk. if a local anaesthetic is necessary, please use an appropriate alternative.
  • Action
    When removing these devices ensure that: you have read the attached information from the manufacturer you have access to small clamps for device removal in case of thread detachment. ACTION DEADLINES FOR THE SAFETY ALERT BROADCAST SYSTEM (SABS) Trust managers should ensure that measures to implement the 'Actions' specified above are planned and completed in line with the following SABS deadlines. Further information about SABS can be found at:


  • Model / Serial
  • Product Description
    Prosan Flexi-T 300 intrauterine devices - batch 01A1.
  • Manufacturer