Bayer plc, a global pharmaceutical company, has received two complaints with regards to its Mirena inserters. The complaints detail that the insertion tube was mounted inversely to the handle, and this has led to an inversion of the insertion depth scale, which may lead to incorrect insertion depth; consequently reducing the efficacy and\/or causing injuries.<\/p>\n
An investigation has shown that both complaints involve one batch of inserters and a Mirena batch number TU01BPE. The affected batch was first distributed on 29th<\/sup> August 2016, with an expiry in June 2019. Bayer issued and distributed a letter to healthcare professionals. The pharmaceutical company note that any stock from the named batch should be thoroughly inspected to ensure the tube is mounted onto the handle correctly.<\/p>\n Bayer enclosed a photograph of both the defective and correctly mounted inserters, and below the photograph, additional guidance is given. This is in hope there will not be any further errors and to ensure any of the incorrectly mounted inserters can be rectified.<\/p>\n In the letter, Bayer gives detailed notes to Healthcare Professionals to follow in order to check if the Mirena inserters they hold are within the ‘defective’ batch. They must:<\/p>\n
\n<\/p>\nAdvice from Bayer<\/h2>\n