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 Codes	Laceration(s) (1946); Pain (1994); Discomfort (2330)
Date of Event	11/14/2024
Type of Reportable Event	Malfunction
Event or Problem Description
The customer went to the er for assistance with removal of flex reusable disc that had been inserted for approximately 30 hours.The customer reported having a headache and feeling anxious and lightheaded.The customer stated that it took the doctor approximately 30 minutes and "a broken pair of forceps" before the flex reusable disc was successfully removed.The customer also stated that the doctor said the disc was like a "tourniquet on her cervix" and the disc was broken during medical removal.Customer reported an internal laceration from medical removal as well.The doctor advised the customer to take tylenol for pain and discomfort.The customer stated she was sore post removal and tylenol did not help.Symptoms did resolve after a few days.The customer was advised by the doctor and by flex to follow up with their primary healthcare provider to discuss their experience.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; #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: 20932105
• Report Number: 3012971814-2024-00024
• Device Sequence Number: 20110153
• Product Code: HHE
• UDI-Device Identifier: 00851906007590
• UDI-Public: 00851906007590
• Combination Product (Y/N): N
• Initial Reporter State: MA
• 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): 12/13/2024

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: 1010505
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/15/2024
• Initial Report FDA Received Date: 12/13/2024
• 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: 29 YR
• Patient Sex: Female