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	12/13/2024
Type of Reportable Event	Malfunction
Event or Problem Description
Customer reported that the pull-tab broke off their size 2 flex cup during attempted removal.As a result, the customer was unable to remove the cup themselves and was seen by a doctor for assistance with removal.The customer stated that the doctor did use tools to assist with removal, but did not specify which tools were used.Visit/treatment notes did not specify which tools were used and stated that the flex cup was removed in one piece.The cup had been inserted for approximately 18 hours at time of removal.The customer reported experiencing no adverse symptoms upon insertion, during use, and following the medically assisted product removal and was not prescribed any medication.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 L4M5K 3; CA L4M5K3
• Manufacturer Contact: cole rocca ; 318 lincoln blvd; #204; venice, CA 90291 ; 4242092711
• MDR Report Key: 21146385
• Report Number: 3012971814-2025-00004
• Device Sequence Number: 21115751
• Product Code: HHE
• UDI-Device Identifier: 00851906007255
• UDI-Public: 00851906007255
• Combination Product (Y/N): N
• Initial Reporter State: IL
• 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
• Type of Report: Initial
• Report Date (Section B): 01/13/2025

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: UNAVAILABLE
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/14/2024
• Initial Report FDA Received Date: 01/13/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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: 33 YR
• Patient Sex: Female