MAUDE Adverse Event Report: THE FLEX COMPANY FLEX; DISPOSABLE MENSTRUAL DISC

Model Number	10005
Medical Device Problem Codes	Difficult to Remove (1528); Patient Device Interaction Problem (4001)
Health Effect - Clinical Code	Pain (1994)
Date of Event	03/05/2024
Type of Reportable Event	Malfunction
Event or Problem Description
The customer contacted the flex company's customer service team for assistance after having some difficulty removing a disposable flex disc and was advised to seek medical assistance.This was the customer's first cycle using a menstrual disc and the disc had been inserted for 16 hours at time of removal.The customer stated that their treating provider utilized a speculum, experienced difficulty removing the device, and commented that the device was suctioned onto the cervix.The customer reported experiencing pain during removal and slight bruising following removal.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: DISPOSABLE 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 L4M 5 K3; CA L4M 5K3
• Manufacturer Contact: jacqueline piscitello ; 318 lincoln blvd.; #204; venice, CA 90291 ; 4242092711
• MDR Report Key: 19042419
• Report Number: 3012971814-2024-00005
• Device Sequence Number: 18263245
• Product Code: HHE
• UDI-Device Identifier: 00851906007590
• UDI-Public: 00851906007590
• 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): 04/04/2024

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: 10005
• Device Lot Number: 94434
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/05/2024
• Initial Report FDA Received Date: 04/04/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Is the Device Labeled for Single Use? (Y/N): Yes
• 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: 41 YR
• Patient Sex: Female