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

Device Problem Difficult to Remove (1528)

Patient Problems Unspecified Infection (1930); Pain (1994); Discomfort (2330)

Event Date 12/23/2020

Event Type  Injury  

Event Description

The customer got in touch with mooncup ltd to inform us that when using the mooncup menstrual cup for the first time over two days of their period, they experienced significant pressure on their bladder.They also experienced difficulty and discomfort when removing the mooncup® with the stem pressing on their vaginal opening uncomfortably.Since using the cup, they report experiencing ongoing discomfort, pain after urinating and a constant dull ache to the urethra.They spoke to their nurse who suggested they may have internal bruising.Following a period of around 6 weeks, the customer has had multiple appointments with doctors.The customer has been treated for cystitis and states that the infection has passed but reports that the inflammation and pressure on their bladder continues.They have undergone a blood test and are awaiting an ultrasound scan (delayed due to the ongoing covid-19 pandemic).The customer reports waking up every night for weeks with the urge to urinate though being unable to do so.The customer reports that they have been left stressed and sleep-deprived by this situation and that they have no prior history of urinary tract or vaginal infections.

• 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 Contact: katherine clements ; vantage point; new england road; brighton, east sussex BN14G-W ; UK BN14GW
• MDR Report Key: 11197669
• MDR Text Key: 227723758
• Report Number: 3009117944-2021-00001
• 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: 01/19/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/19/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 12/23/2020
• 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