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

Model Number	10005
Medical Device Problem Codes	Difficult to Remove (1528); Device-Device Incompatibility (2919); Patient Device Interaction Problem (4001)
Health Effect - Clinical Code	Pain (1994)
Date of Event	06/28/2025
Type of Reportable Event	Malfunction
Event or Problem Description
Customer reported it was difficult to remove the device.Customer went to the emergency room to have the device removed by a medical professional.It was noted that forceps were used to remove the device.Doctor stated the disc had created a suction to customers cervix.In the process of removal, the customer's iud (intrauterine device) was accidentally removed from the suction.Customer experienced pain.The instructions for use that are provided in the packaging with the device state "consult your doctor if you are using an intrauterine device (iud).While uncommon, there is a risk of dislodging, displacing, or removing the iud by pulling on the iud string when removing flex disc." 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: panpan wang ; 318 lincoln blvd. #204; venice, CA 90291 ; 4242092711
• MDR Report Key: 22644568
• Report Number: 3012971814-2025-00021
• Device Sequence Number: 8798664
• Product Code: HHE
• UDI-Device Identifier: 00850037498413
• UDI-Public: 00850037498413
• 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: Consumer
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 07/29/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Lay User/Patient
• Device Model Number: 10005
• Device Lot Number: 1013805
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/03/2025
• Initial Report FDA Received Date: 07/29/2025
• 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
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 40 YR
• Patient Sex: Female