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

Model Number	10112
Medical Device Problem Codes	Difficult to Remove (1528); Patient Device Interaction Problem (4001)
Health Effect - Clinical Code	Pain (1994)
Date of Event	08/13/2024
Type of Reportable Event	Malfunction
Event or Problem Description
The customer contacted the company's customer experience team via phone and sms text messaging to report that they were experiencing difficulty removing the device and that the device had been in place for approximately 24 hours.The customer was advised by the company's customer experience team to seek medical assistance for removal at a local urgent care.This was the first time the customer had used the device, and it had been in place for approximately 33 hours by the time they sought assistance to have the device removed.The customer stated that their treating provider encountered some difficulty and had to use a speculum and forceps to remove the device.The customer also stated that it took approximately 20 minutes to remove the device, which broke during the removal process.The customer stated that they experienced some pain during removal, but did not report experiencing any other adverse symptoms before, durin, or after removal of the device.The company advised the customer to follow the instructions of their treating provider.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: jacqueline piscitello ; 318 lincoln blvd; #204; venice, CA 90291 ; 4242092711
• MDR Report Key: 20208380
• Report Number: 3012971814-2024-00019
• Device Sequence Number: 7202463
• Product Code: HHE
• UDI-Device Identifier: 00851906007590
• UDI-Public: 00851906007590
• Combination Product (Y/N): N
• Initial Reporter State: IL
• 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: Consumer
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 09/12/2024

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: 08/13/2024
• Initial Report FDA Received Date: 09/12/2024
• 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
• Patient Age: 22 YR
• Patient Sex: Female