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

Model Number	10045
Medical Device Problem Codes	Difficult to Remove (1528); Patient Device Interaction Problem (4001)
Health Effect - Clinical Code	Pain (1994)
Date of Event	08/20/2023
Type of Reportable Event	Malfunction
Event or Problem Description
The customer contacted the company's customer experience team via phone and left a voicemail stating that they were having difficulty removing their flex cup.A customer experience agent called the customer back within 30 minutes and provided live assistance for approximately 20 minutes.The customer stated that they believed the cup had flipped upside down as they could not feel the pull tab and could feel the inside of the cup.This was the first time the customer had used the device.The customer indicated that they might seek medical assistance for removal if they were unable to remove the product on their own and requested email follow up.The company's customer experience team followed up with the customer via email the next morning to see if they were able to remove the device or if they sought medical assistance.The customer responded the following day stating that they did obtain a same-day appointment at a clinic where the device was successfully removed.The customer stated that the removal was difficult and painful, and believed the cup was "facing downwards" and "stuck".The customer was advised to discontinue their use of the device and follow up with their primary care provider.The customer failed to respond to three good-faith efforts by the company to obtain additional information regarding the event.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: 17795146
• Report Number: 3012971814-2023-00019
• Device Sequence Number: 2149004
• Product Code: HHE
• UDI-Device Identifier: 00851906007262
• UDI-Public: 00851906007262
• 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): 09/21/2023

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: 10045
• Device Lot Number: UNAVAILABLE
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/22/2023
• Initial Report FDA Received Date: 09/21/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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 Sex: Female