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	02/21/2025
Type of Reportable Event	Malfunction
Event or Problem Description
Customer reported going to urgent care for assistance with removal of flex disposable disc.Customer stated the disc was inserted on february 15th.Customer tried to remove the disc multiple times over the next several days.Customer went to urgent care for assistance with removal on february 21st.The customer stated the urgent care doctor was unable to remove the disc and the customer was sent to the er for further evaluation.The disc was successfully removed by the er doctor at 2:30am on february 22nd.The disc had been inserted for approximately 151 hours total before it was successfully removed by the doctor.The customer stated the doctor used tools to assist with removal but did not specify which.The customer reported some discomfort post removal but was not prescribed any medication.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: DISPOSABLE 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: cole rocca ; 318 lincoln blvd. #204; venice, CA 90291 ; 4242092711
• MDR Report Key: 21715643
• Report Number: 3012971814-2025-00005
• Device Sequence Number: 10010440
• Product Code: HHE
• UDI-Device Identifier: 00851906007248
• UDI-Public: 00851906007248
• 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: User Facility
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 03/27/2025

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: 10005
• Device Lot Number: 1010456
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/23/2025
• Initial Report FDA Received Date: 03/27/2025
• 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: 42 YR
• Patient Sex: Male