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

Model Number	70D
Medical Device Problem Codes	Expulsion (2933); Compatibility Problem (2960)
Health Effect - Clinical Code	Cyst(s) (1800)
Date of Event	04/16/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
User contacted support claiming that an allergic reaction to the menstrual disc (silicone) caused localized cyst development.Location, size, and number of cysts was not communicated.User stated a personal medical history involving allergies to a spermicidal sponge (polyurethane) which also caused cyst development, and an allergy to neoprene which causes welts and eczema.This is being considered a reportable adverse event because cysts are a permanent alteration to body structure and medical intervention is required to correct.Submission of this report does not constitute an admission that the manufacturer's product caused or contributed to the event.

• Brand Name: CORA DISC
• Common Device Name: MENSTRUAL CUP
• Manufacturer (Section D): CASCO BAY MOLDING LTD; 32 smada rd; sanford ME 04073
• Manufacturer Contact: tom kircher ; 32 smada rd; sanford, ME 04073
• MDR Report Key: 14602848
• Report Number: 3003270419-2021-00005
• Device Sequence Number: 17678973
• 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): 06/03/2022

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: 70D
• Device Catalogue Number: 9XFY-J2GT
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/13/2022
• Initial Report FDA Received Date: 06/06/2022
• 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: Disability
• Patient Sex: Female