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	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/25/2023
Type of Reportable Event	Malfunction
Event or Problem Description
The customer left a review on the company's website to report that they had experienced difficulty removing the device and sought medical assistance for removal at a local women's urgent care clinic.This was the first time the customer used the device, and it was in place for approximately 20 hours before being removed.The customer stated that their treating provider also experienced difficulty removing the device, but was eventually able to remove the device using forceps.The customer stated that they have a tilted uterus, and was informed by the medical provider that removed the device that they have a high cervix.The customer stated that they had some mild cramping before removal, but did not report experiencing any adverse symptoms during or after removal.The customer was advised to discontinue use of the device and follow up with their primary care provider.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: 18145689
• Report Number: 3012971814-2023-00026
• Device Sequence Number: 7015778
• Product Code: HHE
• UDI-Device Identifier: 00851906007248
• UDI-Public: 00851906007248
• Combination Product (Y/N): N
• Initial Reporter State: AR
• 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): 11/15/2023

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: 10005
• Device Lot Number: 88455
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/26/2023
• Initial Report FDA Received Date: 11/15/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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: 44 YR
• Patient Sex: Female