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

Model Number	10005
Medical Device Problem Codes	Difficult to Remove (1528); Patient Device Interaction Problem (4001)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/10/2025
Type of Reportable Event	Malfunction
Event or Problem Description
The customer reported going to their doctor for assistance with removal of a disposable flex disc.The disc had been inserted for approximately 36 hours at the time of the assisted removal.The customer indicated that this was their first time using the product and they were unable to remove it themselves.They stated that the doctor completed removal without the use of any tools and the customer was not prescribed any medication.The customer further reported that the doctor states that the customer's pelvic bone made removal of the product difficult.The submission of this report is not an admission by the company that the use of the device in questions caused or contributed to the customer event.

• Brand Name: FLEX
• Common Device Name: DISPOSABLE MENSTRUAL DISC
• Manufacturer (Section D): THE FLEX COMPANY; 318 lincoln blvd.; suite 204; venice CA 90291
• Manufacturer (Section G): SOUTHMEDIC INC.; 50 alliance blvd.; barrie, ontario L4M 5 K3; CA L4M 5K3
• Manufacturer Contact: cole rocca ; 318 lincoln blvd.; suite 204; venice, CA 90291 ; 4242092711
• MDR Report Key: 21905822
• Report Number: 3012971814-2025-00006
• Device Sequence Number: 4085050
• Product Code: HHE
• UDI-Device Identifier: 00851906007149
• UDI-Public: 00851906007149
• 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): 04/24/2025

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
• Device Model Number: 10005
• Device Lot Number: UNAVAILABLE
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/11/2025
• Initial Report FDA Received Date: 04/24/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Is the Device Labeled for Single Use? (Y/N): Yes
• 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: Hospitalization
• Patient Age: 41 YR
• Patient Sex: Female