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	08/07/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
User reported their iud dislodged on the first day of use with a new cora cup.User reports that they think they heard the seal break before trying to remove it.User stated that they check the iud string before and after each use, but the last time the user removed it the user felt the iud sticking out of the cervix.User sought medical attention to remove dislocated iud, however iud broke during removal.User now requires hysteroscopy under general anesthesia to remove broken iud.No injuries or medications reported.Submission of this report does not constitute an admission that the manufacturer's product caused or contributed to the event.
Additional Manufacturer Narrative
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.

• 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: 18640168
• Report Number: 3003270419-2023-00001
• Device Sequence Number: 8042067
• 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): 12/11/2023

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: 09/15/2023
• Initial Report FDA Received Date: 02/05/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Female