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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 Difficult to Remove (1528)
Patient Problems Pain (1994); Prolapse (2475)
Event Date 08/19/2019
Event Type  Injury  
Event Description

The customer contacted mooncup ltd on (b)(6) 2019 via the social media platform (b)(6) to report that having purchased a menstrual cup 2 years ago, and using it for a few months, they were experiencing issues. On one occasion they had difficulties removing the cup, were unable to break the seal and they were able to feel their cervix inside the cup. It took some time to remove the cup and on removal they "felt different inside". The customer reported that they then called a non-emergency medical telephone line and upon their advice attended a hospital's accident and emergency department. The customer reports that they "seem[ed] to have suffered some sort of small prolapse" and have been unable to have intercourse with their partner without extreme pain in the subsequent 2 years. The customer visited their general practitioner (gp) to report what had happened. Having undergone a laparoscopy as the gp felt the customer may have endometriosis, the results showed this was not the case. At the time of this report the customer informs us that they still have no diagnosis and continue to experience pain during intercourse. The customer has since been in contact via email and correspondence is ongoing. At the time of filing this report it has not been confirmed that the menstrual cup involved is a mooncup®.

 
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Brand NameMOONCUP®/ MCUK®
Type of DeviceMENSTRUAL CUP
Manufacturer (Section D)
MOONCUP LTD
vantage point
new england road
brighton, BN1 4 GW
UK BN1 4GW
Manufacturer (Section G)
MOONCUP LTD
vantage point
new england road
brighton, 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
MDR Report Key9006516
MDR Text Key160443080
Report Number3009117944-2019-00003
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
Type of Report Initial
Report Date 09/13/2019
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received09/12/2019
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 Received08/19/2019
Was Device Evaluated By Manufacturer? No
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: 09/12/2019 Patient Sequence Number: 1
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