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	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/03/2024
Type of Reportable Event	Malfunction
Event or Problem Description
The customer contacted the company's customer experience team via email to report that they had experienced difficulty removing the device, and had sought 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 two days before they sought assistance.The customer stated that they could feel the device but could not hook their finger on the rim to remove it.The customer stated that their treating provider at the urgent care tried for approximately 10 minutes to remove the device without success.The provider advised the customer to make an appointment at another urgent care facility for later that day, which the customer did.The treating provider at the second urgent care was able to successfully remove the device with the use of a speculum and forceps.The customer reported experiencing some cramping prior to removal, but did not report any other adverse symptoms during 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: 19672236
• Report Number: 3012971814-2024-00013
• Device Sequence Number: 6617016
• 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): 07/03/2024

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: 06/04/2024
• Initial Report FDA Received Date: 07/03/2024
• 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: 42 YR
• Patient Sex: Female