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

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.

• Brand Name: MOONCUP®/MCUK®
• Type of Device: MENSTRUAL 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 Key: 8878472
• MDR Text Key: 153812865
• Report Number: 3009117944-2019-00002
• 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: 08/09/2019

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: 07/18/2019
• Initial Date FDA Received: 08/09/2019
• 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: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Disability