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	06/14/2023
Type of Reportable Event	Malfunction
Event or Problem Description
The customer contacted the company's customer experience team via text message to report that they were experiencing difficulty removing the device after inserting it over 24 hours before.The event occurred the first time the customer used the device.The company's customer experience team provided live text assistance for two hours, but the customer was still unable to successfully remove the device, so they were advised to seek medical assistance for removal at an urgent care center.The company's customer experience team followed up with the customer the next morning, and the customer confirmed that they went to an urgent care center where the device was successfully removed by a doctor.The customer reported no adverse symptoms following the procedure.The company made three additional good-faith efforts to follow up with the customer via email in order to obtain additional information for our investigation, however, the customer failed to respond.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.; #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: 17330420
• Report Number: 3012971814-2023-00014
• Device Sequence Number: 20351888
• Product Code: HHE
• UDI-Device Identifier: 00851906007590
• UDI-Public: 851906007590
• Combination Product (Y/N): N
• 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: 10112
• Device Lot Number: UNAVAILABLE
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/15/2023
• 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 Sex: Female