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

Model Number	10112
Medical Device Problem Code	Patient Device Interaction Problem (4001)
Health Effect - Clinical Codes	Abdominal Pain (1685); Inflammation (1932); Laceration(s) (1946); Discomfort (2330); Genital Bleeding (4507)
Date of Event	09/16/2025
Type of Reportable Event	Malfunction
Event or Problem Description
Customer reported difficulty removing medical device and experienced cramping several hours prior to removal.They sought medical assistance for removal and needed to use medical instruments for removal.During the removal process, the disc portion broke under the pressure of clamps.The harder rim and retained disc portion remained stuck, requiring further intervention to resolve.The customer reported mild vaginal pain and discomfort due to several removal attempts using instrumentation.They also reported experiencing cervical bleeding and pain due to instrumentation, nausea, lightheadedness, odor, inflammation, tear/laceration/other injury, and pressure.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.
Event or Problem Description
Customer reported difficulty removing medical device and experienced cramping several hours prior to removal.They sought medical assistance for removal and needed to use medical instruments for removal.During the removal process, the disc portion broke under the pressure of clamps.The harder rim and retained disc portion remained stuck, requiring further intervention to resolve.The customer reported mild vaginal pain and discomfort due to several removal attempts using instrumentation.They also reported experiencing cervical bleeding and pain due to instrumentation, nausea, lightheadedness, odor, inflammation, tear/laceration/other injury, and pressure.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, on L4M 5 K3; CA L4M 5K3
• Manufacturer Contact: panpan wang ; 318 lincoln blvd. #204; venice, CA 90291 ; 4242092711
• MDR Report Key: 23372223
• Report Number: 3012971814-2025-00028
• Device Sequence Number: 9119101
• Product Code: HHE
• UDI-Device Identifier: 00851906007590
• UDI-Public: 00851906007590
• Combination Product (Y/N): N
• 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,Followup
• Report Date (Section B): 10/23/2025

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: 1016518
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/23/2025
• Supplement Date Received by Manufacturer: 09/23/2025
• Initial Report FDA Received Date: 10/23/2025
• Supplement Report FDA Received Date: 11/11/2025
• 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: 32 YR
• Patient Sex: Female