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

Model Number	10112
Medical Device Problem Codes	Device-Device Incompatibility (2919); Patient Device Interaction Problem (4001)
Health Effect - Clinical Code	Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581)
Date of Event	04/24/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
The customer left a review on the company's website to report that they had been using the device for approximately two months when they discovered their iud was displaced and they had become pregnant.The company followed up with the customer via email.The customer responded, stating that they were unaware at the time of displacement, but later checked their iud strings and felt that they were lower than usual.The customer stated they were not experiencing their "usual consistent pms symptoms", so they took a pregnancy test which came back positive.Ultrasound imaging was performed at a planned parenthood facility where the customer says it was confirmed that the iud had moved to a lower position "reducing its effectiveness".The customer states they had their iud removed.The customer denied experiencing any adverse symptoms during or after the procedure.The customer was advised by the company that the instructions for use that are provided in the packaging with the device state "consult your doctor if you are using an intrauterine device (iud).While uncommon, there is a risk of dislodging, displacing, or removing the iud by pulling on the iud string when removing flex reusable disc." 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 L4M 5 K3; CA L4M 5K3
• Manufacturer Contact: jacqueline piscitello ; 318 lincoln blvd.; #204; venice, CA 90291 ; 4242092711
• MDR Report Key: 19560071
• Report Number: 3012971814-2024-00012
• Device Sequence Number: 20046497
• Product Code: HHE
• UDI-Device Identifier: 00851906007590
• UDI-Public: 00851906007590
• Combination Product (Y/N): N
• Initial Reporter State: FL
• 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): 06/18/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Lay User/Patient
• Device Model Number: 10112
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/08/2024
• Initial Report FDA Received Date: 06/18/2024
• 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: Reuse
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Age: 33 YR
• Patient Sex: Female