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

Model Number	10045
Medical Device Problem Code	Patient Device Interaction Problem (4001)
Health Effect - Clinical Codes	Hypersensitivity/Allergic reaction (1907); Itching Sensation (1943); Pain (1994); Urticaria (2278)
Date of Event	11/19/2023
Type of Reportable Event	Malfunction
Event or Problem Description
The customer contacted the company's customer experience team via email to report that they believe they have an allergy to silicone after using the device for the first time.The customer reported having extensive known allergies/sensitivities, including benadryl, concerta, luvox, mucinex dm, prednisone, ritalin, tegretol, tosymra, triamcinolone, mometasone, blue star anti-itch ointment, micellar water, most deodorants, most lubricants, costume makeup, adhesives, latex, nickel, heat, dawn dish detergent, tide laundry detergent, cantaloupe, mango, shellfish, and goat's milk.As a result of the customer's multiple allergies, they take a regular dose of 360mg of allegra twice a day.After using the device over the course of two days the customer reported experiencing pain, itching, and hives on their vagina, vulva, and inner thighs within a few hours after inserting the device.The customer further reported that their symptoms resolved a few hours after removing the device, and that they did not seek medical evaluation or treatment.The customer stated that they had "experienced allergic reactions to medications in that area previously and knew how to handle it" and that their symptoms were alleviated by taking their regular allergy medications.The company advised the customer to discontinue their use of the device and follow up with their primary care provider or allergist to discuss the event.The submission of this report is not an admission by the company that the product in question caused or contributed to this event.

• Brand Name: FLEX
• Common Device Name: REUSABLE MENSTRUAL CUP
• 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: 18636106
• Report Number: 3012971814-2024-00004
• Device Sequence Number: 20828591
• Product Code: HHE
• UDI-Device Identifier: 00851906007262
• UDI-Public: 00851906007262
• Combination Product (Y/N): N
• Initial Reporter State: VA
• 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): 02/02/2024

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: 10045
• Device Lot Number: UNAVAILABLE
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/14/2023
• Initial Report FDA Received Date: 02/02/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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
• Patient Age: 24 YR
• Patient Sex: Unknown