MAUDE Adverse Event Report: CASCO BAY MOLDING LTD CORA CUP; MENSTRUAL CUP

Model Number	SIZE 2
Medical Device Problem Code	Patient Device Interaction Problem (4001)
Health Effect - Clinical Code	Prolapse (2475)
Date of Event	03/08/2021
Type of Reportable Event	Serious Injury
Event or Problem Description
User contacted support stating that they had prolapse surgery a year ago and their prolapse had recurred after using the menstrual cup for one cycle.It is unknown if the prolapse recurrence was medically investigated and/or diagnosed, or if the claimed recurred prolapse was of the same type as that which was repaired previously.Support attempted to set up a call with customer to discuss details of the event, their removal method, etc.But the customer failed to respond to further inquiry.Submission of this report does not constitute an admission that the manufacturer's product caused or contributed to the event.

• Brand Name: CORA CUP
• Common Device Name: MENSTRUAL CUP
• Manufacturer (Section D): CASCO BAY MOLDING LTD; 32 smada rd; sanford ME 04073
• MDR Report Key: 11777044
• Report Number: 3003270419-2021-00001
• Device Sequence Number: 11844860
• Product Code: HHE
• UDI-Device Identifier: 00850003218380
• UDI-Public: 00850003218380
• Combination Product (Y/N): N
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: consumer,distributor
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 05/05/2021

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
• Operator of Device: Lay User/Patient
• Device Model Number: SIZE 2
• Device Catalogue Number: 98NA-D87N
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/03/2021
• Initial Report FDA Received Date: 05/05/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other