Events

Safety Alert for Mirena

According to Health Ministry (Panama), this safety alert involved a device in Panama that was produced by Bayer Pharma AG.

What is this?

Alerts provide important information and recommendations about products. Even though an alert has been issued, it does not necessarily mean a product is considered to be unsafe. Safety Alerts, addressed to health workers and users, may include recalls. They can be written by manufacturers, but also by health officials.

Learn more about the data here
  • Type of Event
    Safety alert
  • Date
    2017-05-16
  • Event Date Posted
    2017-05-22
  • Event Country
    Panama
  • Event Source
    HMP
  • Event Source URL
    http://www.minsa.gob.pa/informacion-salud/alertas-y-comunicados?title=&field_decree_date_value%5Bvalue%5D%5Byear%5D=2017&page=6
  • Notes / Alerts
    Panamanian data is current through January 2019. All of the data comes from the Health Ministry (Panama), 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 Panama.
  • Extra notes in the data
  • Reason
    Following the notification of the mirena® product 20mcg / 24 hours (lntrauterine system) in which the findings found in lot tu01btw of the product cited in the reference had been communicated and consequently to the corrective and preventive actions carried out, it informs that the lot tu01btw which was blocked in the international warehouses of bayer j. cain, has been 100% inspected, no unit being found with the inserter assembled incorrectly. as seen in the following image, part of the primary packaging material of the product is transparent, so the position of the inserter is easily visualized without contamination of the product, due to the above we confirm that all units of the tu01btw lot were inspected to ensure that the inserter was in the correct position.

Device

Mirena
  • Model / Serial
  • Product Description
    Mirena® is an intrauterine device that contains levonorgestrel, a progestagen with antiestrogenic activity, that releases 20 µg of the hormone every 24 hours directly into the intrauterine cavity.
  • Manufacturer
    Bayer Pharma AG

Manufacturer

Bayer Pharma AG
  • Manufacturer Parent Company (2017)
    Bayer AG
  • Source
    HMP