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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 Adverse Event Without Identified Device or Use Problem (2993)
Patient Problem Pain (1994)
Event Date 07/18/2019
Event Type  Injury  
Event Description

The customer contacted mooncup ltd on (b)(6) 2019 via the social media platform (b)(6) to make us aware of damage to the right side of her pelvic floor when removing the cup. The customer also describes pain in her bladder on the right side when her bladder fills. The customer states that this first occurred in (b)(6) 2016 with only brief periods of respite since with the symptoms returning in (b)(6) 2019. The customer reports that she has been under the care of a physiotherapist, gynaecologist and general practitioner (gp) since the onset of the symptoms. Mooncup ltd have asked the customer to contact the mooncup ltd advice service directly so that further investigation can be undertaken however at the time of this report the customer has not been back in contact. As such it has not been possible to confirm that the menstrual cup in question is a mooncup® or if the customer has been given a specific diagnosis.

 
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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 Key8878472
MDR Text Key153812865
Report Number3009117944-2019-00002
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
Type of Report Initial
Report Date 08/09/2019
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received08/09/2019
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 Received07/18/2019
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 Unkown

Patient TREATMENT DATA
Date Received: 08/09/2019 Patient Sequence Number: 1
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