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

Device Problem Patient Device Interaction Problem (4001)

Patient Problem Abortion (1688)

Event Date 11/10/2020

Event Type  Injury  

Event Description

The customer contacted mooncup ltd to inform us that their intrauterine contraception (iud/ius) had been expelled during a period of time when they were also using the mooncup menstrual cup.The customer purchased their mooncup® and then had the iud/ius fitted a short time later.The customer indicates that they forgot to check the iud strings between periods.At some point later the iud/ius was expelled without the customer being aware of it.The customer then fell accidentally pregnant, and subsequently had a termination.They also required several hospital follow ups to try and locate the iud/ius.The customer bought the mooncup at a fair stand and was told by the seller that it should be ok to use it with an iud/ius.At the time of purchase the mooncup menstrual cup instructions for use (ifu) stated, "in some instances an iud/ius may be dislodged when used in conjunction with a mooncup.If you choose to use the mooncup with an iud/ius and think your iud/ius is causing pain or suspect it has moved, use another form of contraception such as a condom and have your iud/ius checked by a medical professional." since this time the mooncup instructions for use have also been updated to advise that if considering using the mooncup menstrual cup alongside an iud/ius you should first consult your iud fitter, or doctor to discuss if this is suitable.The customer indicates that at the time of purchase they also read the faq on the mooncup website related to using the mooncup alongside an iud/ius.This faq states: we know that there are mooncup® users who are happily using their mooncup alongside an iud/ius (coil), however, there have been some instances where an iud/ius has become dislodged when using the devices together.This may be due to anatomical factors (e.G.A low cervix), usage issues (e.G.Wearing the mooncup too high) or simply that the iud/ius has been naturally rejected by the body.One in twenty iud/ius will be expelled, most commonly, in the first 3 months after the device has been inserted.These expulsions happen most frequently during menstruation.If you are using the mooncup menstrual cup alongside an iud/ius, check you can still feel the iud/ius strings after each period.If you cannot feel them or 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/ius checked by a doctor, or medical professional.If you are thinking about using the mooncup menstrual cup alongside an iud/ius, consult your doctor, iud/ ius fitter, or gynaecologist first.If you would like to take a mooncup® usage guide to your consultation please contact us.Please also consider the following information: there should always be a space between the mooncup and the cervix.If you have a low sitting cervix there may not be enough room for the mooncup to sit safely and work effectively alongside your iud/ius.The mooncup is designed to be worn as low as it will comfortably sit in the vagina and form a light seal with the walls of the vagina read more about mooncup positioning).It is important to release the seal before removing the mooncup.

• Brand Name: MOONCUP/ MCUK
• Type of Device: MENSTRUAL 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: eileen greene ; vantage point; new england road; brighton, east sussex BN1 4-GW ; UK BN1 4GW
• MDR Report Key: 10943156
• MDR Text Key: 219494408
• Report Number: 3009117944-2020-00003
• Device Sequence Number: 1
• Product Code: HHE
• Combination Product (y/n): N
• PMA/PMN Number: K060852
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Type of Report: Initial
• Report Date: 12/03/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• 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
• Initial Date Manufacturer Received: 11/10/2020
• Initial Date FDA Received: 12/03/2020
• 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: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Other