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

Model Number	RED S
Medical Device Problem Code	Difficult to Remove (1528)
Health Effect - Clinical Code	Abnormal Vaginal Discharge (2123)
Type of Reportable Event	Malfunction
Event or Problem Description
Customer reported that after using the cup for 2.5 days it appeared to be lodged and she was not able to remove it.Approximately 48 hours later she started to feel lethargic and noticed spotting again.She once again tried to remove the cup and was able to this time.She then experienced discharge and smell for almost 2.5 weeks that required treatment to resolve.

• 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: 10826162
• Report Number: 3011660924-2020-00017
• Device Sequence Number: 3204395
• Product Code: HHE
• UDI-Device Identifier: 00850008236006
• UDI-Public: 00850008236006
• Combination Product (Y/N): N
• Initial Reporter State: CA
• 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: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 11/11/2020

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: RED S
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/06/2020
• Initial Report FDA Received Date: 11/11/2020
• 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