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

Device Problem Difficult to Remove (1528)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 06/07/2019

Event Type  malfunction  

Event Description

The correspondent reported that their (b)(6) daughter had an assisted removal of their menstrual cup under general anaesthetic.At the time of this report it has not been established that the menstrual cup was a mooncup®.The menstrual cup was reported to have been left in situ overnight then not emptied the following morning.The menstrual cup user tried throughout the day to remove it but could not get the rim of the menstrual cup out.The mother was not aware of this situation until almost 24 hours after insertion.Further attempts were made to remove the menstrual cup by medical healthcare professionals which resulted in an assisted removal under general anaesthetic in hospital after being in situ for approximately 36 hours.The user had been removing it more frequently the day before.She had researched her period options and wanted an effective eco friendly period protection.The correspondent also reported that her daughter had previously inserted and removed the menstrual cup successfully the day before.

• 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: 8753307
• MDR Text Key: 166345599
• Report Number: 3009117944-2019-00001
• 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: 07/02/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/02/2019
• 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
• Date Manufacturer Received: 06/07/2019
• 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: Reuse
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization
• Patient Age: 12 YR