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

Model Number	10045
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Abdominal Pain (1685); Abscess (1690); Bacterial Infection (1735); Fever (1858)
Date of Event	10/27/2023
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 admitted to the hospital for ir drainage of a tubo-ovarian abscess (toa) after experiencing four days of fever and abdominal/pelvic pain.The customer was diagnosed with a large left toa and ir drainage was performed on their date of admission.Daily lab work was drawn, and the customer received iv antibiotics for three days while in the hospital.The customer was prescribed additional antibiotics after discharge to complete a 14-day course, and the drain was removed on (b)(6) 2023.The customer did not report experiencing any adverse symptoms or other issues after discharge from the hospital.The customer alleged that their infection and toa were linked to their menstrual cup use.Although the customer claims they had been using the device for approximately four months without issue before the incident, no information was provided regarding timing of the use of the device before the onset of symptoms.In addition, the limited medical records provided by the customer do not mention the device or any other source of the infection.Finally, based on a survey of publicly available research, toa is most commonly caused by untreated pelvice inflammatory disease.See: https://www.Medicalnewstoday.Com/articles/tubo-ovarian-abscess#what-is-it, ncbi.Nlm.Gov/books/nbk448125/.Therefore, no conclusive evidence exists to isolate the device as the direct cause of this event.The company advised the customer to discontinue use of the device and follow the instructions of their treating providers.The company made three additional good-faith efforts to obtain further medical records and information from the customer, however, they stopped responding to the company's outreach.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 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: 18297947
• Report Number: 3012971814-2023-00027
• Device Sequence Number: 17924679
• Product Code: HHE
• UDI-Device Identifier: 00851906007262
• UDI-Public: 00851906007262
• Combination Product (Y/N): N
• Initial Reporter State: MA
• 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): 12/08/2023

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: 10045
• Device Lot Number: 91089
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/08/2023
• Initial Report FDA Received Date: 12/08/2023
• 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
• Outcome Attributed to Adverse Event: Required Intervention; Hospitalization
• Patient Age: 38 YR
• Patient Sex: Female