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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MOONCUP LTD MOONCUP®/ MCUK® MENSTRUAL CUP

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MOONCUP LTD MOONCUP®/ MCUK® MENSTRUAL CUP Back to Search Results
Device Problem Device Dislodged or Dislocated (2923)
Patient Problems Ectopic Pregnancy (1819); Miscarriage (1962); Pain (1994)
Event Date 07/01/2012
Event Type  Injury  
Manufacturer Narrative

Statement: the iud expulsion rate for all iud users is around one in twenty (mooncup® user or not) within five years of the iud being inserted. Evidence: there are a small proportion of iuds that are naturally expelled within 5 years. Expulsion of an iud/ius occurs in approximately 1 in 20 women, and is most common in the first three months after insertion. Expulsion commonly occurs during menstruation. Reference: mechanism of action, safety and efficacy of intrauterine devices. Report of a who scientific group. Technical report series 753. Geneva: world health organisation; 1987. Reference: (b)(4) guidelines. Long-acting reversible contraception the effective and appropriate use of long-acting reversible contraception. October 2005. (b)(4). Statement: with correct positioning and usage the mooncup ® can be used by women with an iud. Evidence: there were no significant differences in expulsion rates less than 6 weeks after iud insertion between women who used only pads compared to women who used either tampons or menstrual cups. In our study, the cup users were younger, were more likely to be nulliparous and were more likely to use copper iuds, but still did not have higher expulsion rates. From this study, there is no evidence that women who report using menstrual cups or tampons for menstrual protection had higher rates of early iud expulsion. Reference: wiebe e & trouton k (2011) does using tampons or menstrual cups increase early iud expulsion rates? department of family practice, university of british columbia, vancouver bc, canada v5z1h9. Statement: you may choose to discuss this with your doctor/nurse/gynaecologist if you have concerns or you feel that your mooncup may interfere with your iud strings. Evidence: neither a tampon nor a cup would normally be in contact with an iud string, and the type of contact involved would not be adequate to remove a well placed iud. Evidence: women should be advised how to check for the presence of iud threads and encouraged to do this regularly with the aim of recognising expulsion. Statement: when an iud has first been inserted, you should wait six weeks before using a mooncup® (or any internal sanitary protection) evidence: increased risk of infection in the first 3 weeks after insertion of ius/ius. Reference: grimes da (2000) intrauterine device and upper-genital-tract infection. Lancet. Sep 16;356(9234):1013-9. Evidence: (b)(4), mooncup advisor was contraceptive and sexual health nurse between 1997 and 2011. She worked in many (b)(4) contraceptive clinics during this time and all recommended no internal sanitary products for 6 weeks post iud/ius fit. This is mainly due to the increased risk of infection. It appears from looking on the internet that some other countries say 48 hours for tampons. Statement: remember to place the mooncup® low in the vagina and ensure you have an adequate seal. It is important to always release the seal before removing a mooncup®. After each period, check you can still feel the iud strings. Evidence: theoretically, when a menstrual cup is removed, suction force could displace the iud string and iud downwards. Cups do produce some suction, and women are usually advised (with or without iuds) to break the suction before removing the cup. Neither a tampon nor a cup would normally be in contact with an iud string, and the type of contact involved would not be adequate to remove a well placed iud. Statement: if you cannot feel them (strings), think that your iud/ius has moved or is causing/has caused you pain, use another form of contraception such as a condom until you have had your iud checked by a doctor/medical professional. Evidence: it's very unlikely that your iud will come out, but if you can't feel the threads or if you think the iud has moved, you may not be fully protected against pregnancy. See your gp or clinician straight away and use extra contraception until your iud has been checked. If you've had sex recently, you may need to use emergency contraception. (b)(4). Device retained by customer.

 
Event Description

The customer reported that on her third month of mooncup® use, on removal of the mooncup®, she felt a sharp pain and thought that when removing the mooncup® it may have dislodged her intrauterine contraceptive device. She had an examination with her practice nurse at her medical centre and was told that the intrauterine contraceptive device was still present. The customer did not continue to use the mooncup®. Two months later, she was informed that she was pregnant and it was diagnosed as an ectopic pregnancy. When she contacted mooncup ltd, she was in the process of miscarrying and had had surgery and drug treatment to remove the embryo. Her fallopian tube then ruptured on (b)(6) 2012 and she was admitted for emergency surgery to remove her fallopian tube.

 
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Brand NameMOONCUP®/ MCUK®
Type of DeviceMENSTRUAL CUP
Manufacturer (Section D)
MOONCUP LTD
vantage point
new england road
brighton, east sussex BN1 4 GW
UK BN1 4GW
Manufacturer (Section G)
MOONCUP LTD
vantage point
new england road
brighton, east sussex BN1 4 GW
UK BN1 4GW
Manufacturer Contact
simon boyd-jones
vantage point
new england road
brighton, east sussex BN1 4-GW
UK   BN1 4GW
4412736738
MDR Report Key6968417
MDR Text Key90454566
Report Number3009117944-2016-00002
Device Sequence Number1
Product Code HHE
Combination Product (Y/N)N
PMA/PMN NumberK060852
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type COMPANY REPRESENTATIVE,FOREIG
Remedial Action Relabeling
Type of Report Initial
Report Date 03/30/2016
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received10/23/2017
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator LAY USER/PATIENT
Was Device Available For Evaluation? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received11/14/2012
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Is The Device Single Use? No
Is this a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse

Patient TREATMENT DATA
Date Received: 10/23/2017 Patient Sequence Number: 1
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