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

Model Number	10112
Medical Device Problem Code	Patient Device Interaction Problem (4001)
Health Effect - Clinical Codes	Hypersensitivity/Allergic reaction (1907); Pain (1994); Burning Sensation (2146); Swelling/ Edema (4577)
Date of Event	10/01/2023
Type of Reportable Event	Malfunction
Event or Problem Description
The customer contacted the flex company's customer experience team via email stating that they had experienced a localized allergic reaction while using the device in early (b)(6) 2023.This was the customer's first time using the device.The customer stated that within approximately one to two hours of inserting the device they began to experience localized pain, swelling, and a burning sensation.The customer promptly removed the device, which did not alleviate their symptoms, so they sought evaluation and treatment at a local urgent care.The customer stated that their treating provider prescribed a course of prednisone, and that their symptoms were completely resolved after approximately three days.The customer has a known allergy to latex.The customer did not report any lingering symptoms or issues following the event.The company advised the customer to discontinue their use of the device and follow the instructions of their treating 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: 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: 19055906
• Report Number: 3012971814-2024-00006
• Device Sequence Number: 12808973
• Product Code: HHE
• UDI-Device Identifier: 00851906007262
• UDI-Public: 00851906007262
• 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): Unknown
• Reporter Type: Manufacturer
• Report Source: Consumer
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 04/05/2024

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: 03/06/2024
• Initial Report FDA Received Date: 04/05/2024
• 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: 35 YR
• Patient Sex: Female