Class 4 Caution in Use : Mirena 20 micrograms / 24 hours intrauterine delivery system

Bayer plc has informed us that they have received two complaints globally concerning Mirena inserters with an insertion tube which is mounted inversely to the handle

Product Information

EL number

EL 17(A) 02

MDR number

MDR 051-12/16

Product description

Mirena 20 micrograms / 24 hours intrauterine delivery system - PL 0001/0547

Batch number Expiry Date Pack Size First Distributed
TU01BPE June 2019 1x1 29 August 2016

Brief description of the problem

Bayer plc has informed us that they have received two complaints globally concerning Mirena inserters with an insertion tube which is mounted inversely to the handle. This has resulted in inversion of the insertion depth scale, which may lead to incorrect insertion depth and the possibility of a reduced efficacy or adverse events. A very small number of Mirena inserters may potentially be affected by this issue.

An investigation has shown that both complaints involve one batch of inserters and Mirena batch TU01BPE has been manufactured using inserters from the same batch.

Any incorrectly mounted insertion tubes identified should be reported to Bayer plc by telephone, 01635 563116 or by email to medical.information@bayer.co.uk

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Mirena 20 micrograms / 24 hours intrauterine delivery system

More detailed advice for Healthcare Professionals can be found in the attached letter, which has also been distributed by Bayer.

Recipients of this Drug Alert should bring it to the attention of relevant contacts by copy of this letter. NHS Regional Teams are asked to forward this to relevant clinics, general practitioners and community pharmacists.

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