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

Model Number	10046
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	08/08/2023
Type of Reportable Event	Malfunction
Event or Problem Description
The customer reached out to the company's customer experience team via email and stated that they used a size 1 flex cup for a few months then switched to the size 2 flex cup and used it for approximately six months without incident.The customer stated that while wearing the cup overnight, it shifted and they were unable to remove it.The customer went to the emergency room for assistance with removal of the cup.The customer did not indicate how long the device had been in place prior to removal.The customer indicated that two physicians worked to remove the device and had a difficult time.The customer stated that one of the physicians informed the customer that the cup had shifted to "the top of my cervix".No adverse symptoms were reported by either the customer or the physicians during or after removal of the device.The customer was advised to discontinue their use 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: REUSABLE MENSTRUAL CUP
• 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: 17695816
• Report Number: 3012971814-2023-00018
• Device Sequence Number: 20394916
• Product Code: HHE
• UDI-Device Identifier: 00851906007255
• UDI-Public: 00851906007255
• Combination Product (Y/N): N
• Initial Reporter State: NC
• 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): 09/06/2023

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: 10046
• Device Lot Number: 88509
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/08/2023
• Initial Report FDA Received Date: 09/06/2023
• 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: Reuse
• Patient Sequence Number: 1
• Patient Age: 50 YR
• Patient Sex: Female