MAUDE Adverse Event Report: THE FLEX COMPANY FLEX; FLEX CUP, SIZE 1

Model Number	10043
Medical Device Problem Codes	Difficult to Remove (1528); Patient Device Interaction Problem (4001)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	01/24/2023
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 having difficulty removing the device and sought medical assistance to assist with removal.The event occurred the first time the customer used the device.The customer stated that they followed the instructions on the package labeling for insertion and removal.The customer further stated that upon insertion, the stem retreated back inside of the device.They tried for two hours but were unable to remove the device to correct the issue, so they sought medical assistance.The customer stated that they did not have intercourse with the device inserted, nor were they aware of any physical nuances that would have contributed to the difficult removal.The customer stated that the nurse practitioner was unable to remove the device using a speculum as a visual aid; subsequently, they state it took a physician 4 attempts to remove the device.This device is designed so that it can be removed with a pull-tab but may also be removed like a traditional menstrual cup without the pull-tab.Per the instructions for use provided with the device "if the pull-tab is not working, flex cup can be removed by pinching the base of the cup to release the suction".

• Brand Name: FLEX
• Common Device Name: FLEX CUP, SIZE 1
• 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: 16529852
• Report Number: 3012971814-2023-00003
• Device Sequence Number: 19494380
• Product Code: HHE
• UDI-Device Identifier: 00851906007262
• UDI-Public: 851906007262
• Combination Product (Y/N): N
• Initial Reporter State: AZ
• 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
• Remedial Action: Other
• Type of Report: Initial
• Report Date (Section B): 03/10/2023

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: 10043
• Device Lot Number: 162394
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/24/2023
• Initial Report FDA Received Date: 03/13/2023
• 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 Age: 27 YR
• Patient Sex: Female