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

Model Number	SIZE 1
Medical Device Problem Codes	Expulsion (2933); Compatibility Problem (2960)
Health Effect - Clinical Codes	Menstrual Irregularities (1959); Intermenstrual Bleeding (2665)
Date of Event	07/23/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The skyla iud is intended for three years of use and this is how long it was inserted in the user at the time of incident.It is unclear if the iud was already expelling when the user inserted the cup and felt pressure, or if incorrect placement or natural shifting of the iud over time contributed to this event.A statistical analysis of complaints and uses indicates that casco's rate of iud-related events is equal or less than the rate of spontaneous iud expulsion across all users of all catamenial devices in the literature.
Event or Problem Description
User contacted support indicating that after inserting the menstrual cup there was a lot of pressure so the user immediately removed the cup and her iud came out with it.Further conversation with user revealed that they never consulted their ob/gyn prior to use as indicated on labeling.The brand of iud involved was skyla.User intended to seek medical treatment for the insertion of a new iud but otherwise no injuries/medications/interventions were necessary.

• 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: 12582758
• Report Number: 3003270419-2021-00002
• Device Sequence Number: 3787928
• 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): 10/06/2021

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 1
• Device Catalogue Number: Z38W-1XD3
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/03/2021
• Initial Report FDA Received Date: 10/06/2021
• 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