MAUDE Adverse Event Report: THE FLEX COMPANY FLEX; REUSABLE MENSTRUAL DISC

Model Number	10112
Medical Device Problem Codes	Difficult to Remove (1528); Patient Device Interaction Problem (4001)
Health Effect - Clinical Codes	Pain (1994); Discomfort (2330)
Date of Event	04/02/2025
Type of Reportable Event	Malfunction
Event or Problem Description
Customer reported seeking medical assistance from their obgyn for the removal of a reusable flex disc.Customer stated the disc had been in place for approximately 16 hours at time of removal.The customer stated the doctor used tools to assist with removal but did not specify which.Customer reported some pain/discomfort due to the experience, but did not have any serious adverse symptoms - customer stated pain/discomfort resolved immediately after product removal and was not prescribed any medication by their doctor.Customer reported that the obgyn stated they have a high cervix and a menstrual cup would be a better product for their anatomy.The submission of this report is not an admission by the company that the use of the device in question caused or contributed to the customer event.

• Brand Name: FLEX
• Common Device Name: REUSABLE MENSTRUAL DISC
• Manufacturer (Section D): THE FLEX COMPANY; 318 lincoln blvd #204; venice CA 90291
• Manufacturer (Section G): SOUTHMEDIC INC.; 50 alliance blvd.; barrie, ontario L4M 5 K3; CA L4M 5K3
• Manufacturer Contact: panpan wang ; 318 lincoln blvd. #204; venice, CA 90291 ; 8009310882
• MDR Report Key: 22842952
• Report Number: 3012971814-2025-00023
• Device Sequence Number: 14678131
• Product Code: HHE
• UDI-Device Identifier: 00851906007590
• UDI-Public: 00851906007590
• Combination Product (Y/N): N
• Initial Reporter State: CA
• 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: Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 08/14/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Lay User/Patient
• Device Model Number: 10112
• Device Lot Number: 1003984
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/20/2025
• Initial Report FDA Received Date: 08/19/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 45 YR
• Patient Sex: Female