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	Itching Sensation (1943); Burning Sensation (2146)
Date of Event	08/27/2025
Type of Reportable Event	Malfunction
Event or Problem Description
The customer attempted to use the disc multiple times, but reported experiencing the same itching/burning sensation from using them.Initially, the customer thought it was a yeast infection and started monistat, but after seeking medical attention, the vaginal swabs were negative for yeast and bv.Their health provider prescribed fluconazole, which helped to resolve their symptoms.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: 23318540
• Report Number: 3012971814-2025-00027
• Device Sequence Number: 4967379
• Product Code: HHE
• UDI-Device Identifier: 00851906007590
• UDI-Public: 0851906007590
• 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
• Report Date (Section B): 10/16/2025

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
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/17/2025
• Initial Report FDA Received Date: 10/16/2025
• 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: Reuse
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 37 YR
• Patient Sex: Female