MAUDE Adverse Event Report: THE FLEX COMPANY FLEX; SINGLE-USE MENSTRUAL DISC

Model Number	10005
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	06/15/2023
Type of Reportable Event	Malfunction
Event or Problem Description
The customer contacted the company's customer experience team via email to report that they were experiencing difficulty removing the device and sought medical assistance for removal after it had been in place for approximately 20 hours.The event occurred the first time the customer used the device.The customer stated that they had sexual intercourse while the device was inserted, and that they tried to remove the device for approximately eight hours before seeking medical assistance at an urgent care center.The customer stated that the nurse practitioner at the urgent care encountered some difficulty removing the device, but they were eventually able to successfully remove the device.The customer stated that the device broke when it was removed, however, no adverse symptoms were reported by either the customer or the nurse practitioner after removal of the device.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: SINGLE-USE MENSTRUAL DISC
• Manufacturer (Section D): THE FLEX COMPANY; 318 lincoln blvd.; #200; 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.; #200; venice, CA 90291 ; 4242092711
• MDR Report Key: 17330438
• Report Number: 3012971814-2023-00015
• Device Sequence Number: 14981930
• Product Code: HHE
• UDI-Device Identifier: 00851906007262
• UDI-Public: 851906007262
• Combination Product (Y/N): N
• Initial Reporter State: WI
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Consumer
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 07/14/2023

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: 10005
• Device Lot Number: 171546
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/16/2023
• Initial Report FDA Received Date: 07/14/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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