MAUDE Adverse Event Report: LENA CUP LLC LENA; MENSTRUAL CUP

Model Number	LENA-MIXII-1
Medical Device Problem Code	Patient Device Interaction Problem (4001)
Health Effect - Clinical Code	Fungal Infection (2419)
Type of Reportable Event	Malfunction
Event or Problem Description
User reported that she experienced itchiness during cup use and her doctor prescribed medication for yeast infection and the symptoms subsided.She had initially used dial antibacterial soap for cleaning the cup, but even after boiling only with water, she again experienced the same symptoms and therefore decided to discontinue use.

• Brand Name: LENA
• Common Device Name: MENSTRUAL CUP
• Manufacturer (Section D): LENA CUP LLC; 244 fifth avenue #2243; new york NY 10001
• MDR Report Key: 10806560
• Report Number: 3011660924-2020-00016
• Device Sequence Number: 17093654
• Product Code: HHE
• UDI-Device Identifier: 00850008236129
• UDI-Public: 00850008236129
• Combination Product (Y/N): N
• Initial Reporter State: OH
• 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): 11/08/2020

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: LENA-MIXII-1
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/04/2020
• Initial Report FDA Received Date: 11/08/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other