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: TU01BPE
- Expiry Date: June 2019
- Pack Size: 1x1
- First Distributed: 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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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.